Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584266
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-31
Brief Title:
Multimodal Cardiac Imaging Registry in Patients with Atrial Fibrillation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multimodal Multicentre Registry of Clinical and Imaging Data to Develop Predictive Models Based on Artificial Intelligence to Support the Diagnostic and Therapeutic Process for Patients with Atrial Fibrillation Undergoing Catheter Ablation and Cardioversion
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMAGE-AF
Brief Summary:
The goal of this observational registry is to collect a curated dataset of multimodal imaging data that will serve for development of artificial-intelligence based solutions for prediction of risk and outcomes in patients with atrial fribrillation
Type of study observational study
Study Participants Patients with atrial fibrillation or atrial flutter who undergo clinically indicated transesophageal echocardiography before catheter ablation or cardioversion
We hypothesize that automatic analysis of video images of transthoracic echocardiography with deep learning combined with clinical data can predict the presence of left atrial appendage thrombus LAT Therefore our main aim is to create and validate an artificial intelligence model to predict the presence of LAT based on automatic analysis of transthoracic echocardiography with artificial intelligence
Type of study observational study
Study Participants Patients with atrial fibrillation or atrial flutter who undergo clinically indicated transesophageal echocardiography before catheter ablation or cardioversion
We hypothesize that automatic analysis of video images of transthoracic echocardiography with deep learning combined with clinical data can predict the presence of left atrial appendage thrombus LAT Therefore our main aim is to create and validate an artificial intelligence model to predict the presence of LAT based on automatic analysis of transthoracic echocardiography with artificial intelligence
Detailed Description:
1 Introduction
Atrial fibrillation AF is the most common cardiac arrythmia that affects 37 Europeans over 55 years old representing a major burden for the society and health systems One of the most devastating consequences of AF is ischemic stroke often caused by embolization of cerebral arteries with a left atrial appendage thrombus LAT which can form in left atrial appendage in the presence of AF As it has little contractility on its own emptying and filling of left atrial appendage relies on the function of the left ventricle and the left atrium
AF as well as atrial flutter promote the formation of LAT and are therefore associated with an increased risk of thromboembolic events The mechanism of stroke is complex but embolization with LAT accounts for the majority of events and it can be triggered by sinus rhythm restoration through procedures commonly performed in patients with AF - cardioversion or catheter ablation Therefore cardioversion and catheter ablation in the presence of LAT are contraindicated
Transoesophageal echocardiography TEE is considered the modality of choice to detect LAT with high sensitivity and specificity and is currently recommended before cardioversion or catheter ablation as an alternative to a 3-week course of oral anticoagulation Current guidelines however leave room for an individual decision to either perform or not perform TEE before catheter ablation or cardioversion in a chronically anticoagulated patient but suggest no tools to assess the risk of LAT To address this unmet clinical need we have previously shown that by combining clinical data and measurements from transthoracic echocardiography in a machine-learning model it is possible to predict the risk of LAT formation Importantly our results indicated that TTE-derived measurements played the greatest role in predicting LAT
Despite significant advancements in interventional technologies the selection of appropriate therapeutic methods and perioperative procedures remains a significant challenge Patients eligible for interventional procedures related to AF often undergo numerous diagnostic tests including computed tomography of the heart transoesophageal and transthoracic echocardiography electrocardiography EKG and electroanatomic mapping during the ablation procedure Non-invasive multimodal imaging plays central role in the peri-ablation period informing important therapeutic decisions and facilitating the procedure The essence of this project is the prospective collection of high-quality imaging data from these multiple modalities and clinical data which will allow for a better understanding of the relationships between anatomy hemodynamic function and clinical observation in patients with AF in the future Ultimately the data might serve for the development of tools which could efficiently predict the risk of LAT by means of less invasive and cheaper approaches than the ones which are currently used The resulting multimodal database will also form a foundation for future studies targeted at informing therapeutic decisions in patients undergoing catheter ablation of AF
2 Study Objectives
21 Main objective To create a multimodal multicentre registry of clinical and imaging data to develop predictive models based on state-of the art artificial intelligence to support the diagnostic and therapeutic process for patients undergoing AF catheter ablation and cardioversion
22 Specific objectives
221 Specific Aim 1 Creation of artificial intelligence-based models to predict the risk of formation of left atrial appendage thrombus and estimate the left atrial appendage emptying velocity obtained from transoesophageal echocardiography based on the analysis of transthoracic echocardiographic images and clinical data
222 Specific Aim 2 Assessment of inter-reader and intra-reader agreement in the clinical interpretation of left atrial appendage images and left atrial appendage thrombus diagnosis in transoesophageal echocardiography
223 Specific Aim 3 Development of models that fuse information from multiple modalities for instance from transthoracic echocardiography and cardiac CT to provide better prognosis and guide therapeutic decisions in patients with atrial fibrillation
224 Specific Aim 4 Comparison of the effectiveness of different methods of imaging the left atrium in predicting thromboembolic events
225 Specific Aim 5 Creation of a high-quality multicentre imaging database for additional future auxillary nalyses and studies
3 Study Methodology
To maximize the amount of collected data the study allows both retrospective and prospective data collection The scope of collected data is the same in retrospective and prospective collection with certain data types being optional and subject to availability
31 Inclusion criteria
Patients with
history of atrial fibrillation
who are undergoing medically justified transoesophageal echocardiography to assess the presence of left atrial appendage thrombus before catheter ablation of atrial fibrillation including patients who had transoesophageal echocardiography during the ablation procedure OR
who undergo catheter ablation without prior transoesophageal echocardiography if the center also collects additional imaging data listed in point 25 below 32 Exclusion criteria
Age lt 18 years old
33 33 Types of collected data
Data type Clinical data Compulsory or optional Includes compulsory and optional fields Format Tabular collected using a dedicated eCRF Additional remarks The detailed list of fields with possible values is shown in Appendix 1
Data type TTE Compulsory or optional Compulsory Format DICOM Additional remarks Recorded before TEE preferably on the same day In case of retrospective data TTE and TEE acquired within 72h
Data type TEE Compulsory or optional Compulsory if the patient had TEE Format DICOM
Additional remarks
Data type Cardiac CT Compulsory or optional Optional Format DICOM Additional remarks Contrast enhanced cardiac CT before ablation procedure Can be a study performed for EP planning or for CAD diagnostics Any study performed before the ablation regardless of timing can be used
Data type Non-contrast Cardiac CT Compulsory or optional Optional Format DICOM Additional remarks Non-contrast chest CT Preferred is ECG-gated calcium scoring CT reconstructed with thin slices preferably 05mm
Data type Cardiac Magnetic Resonance CMR Compulsory or optional Optional Format DICOM
Additional remarks
Data type Digitalised Electrocardiogram Compulsory or optional Optional Format DICOM or pdf Additional remarks Performed on the day of the catheter ablation or cardioversion or day before
Data type Electroanatomical map Compulsory or optional Optional Format Proprietary Additional remarks Not to be transferred but only stored locally in the participating center for possible ancillary studies
Data type Follow-up for MACE Compulsory or optional Optional Format Event date Additional remarks Depending on the local regulations and possibility the follow-up data for all-cause mortality stroke myocardial infarction onset or worsening of heart failure will be obtained based on ICD-9 and ICD 10 codes from the national health insurance databases Alternatively data can be obtained by telephone interview
Data type Follow-up for AF Compulsory or optional Optional Format Event date Additional remarks Depending on the local availability of follow-up data for AF recurrence
34 Guidelines for data acquisition
341 Guidelines for Acquisition of Transthoracic and Transesophageal Echocardiography
For prospective collection the TEE and TEE should be performed ideally in the same day TTE directly before TEE For the retrospective cohort TTE can be acquired up to 3 days before TEE as long as there were no important changes in patients condition during this period ie clinical worsening change of rhythm heart rate etc
ECG electrodes should be connected for both TTE and TEE not compulsory for retrospective data
The acquisition length should be set to 5 seconds set the start acquisition at the moment when acquire button is pressed to minimise unwanted movement For retrospective data shorter clips are acceptable
3411 Acquisition of TTE filenames are given in brackets
1 Four-chamber apical projection 4chdcm
2 Two-chamber apical projection 2chdcm
3 Three-chamber apical projection 3chdcm
4 Four-chamber apical projection - optimized for LA 4chLAdcm
5 Two-chamber apical projection - optimized for LA 2chLAdcm
6 3D full volume preferably acquired from 4 or more heart cycles 3d_ttedcm The projections must encompass the entire heart including the atria Measurements to be performed at site if impossible some of these measurements can also be performed by the coordinating site
-- --
1 Cardiac chamber dimensions PLAX plaxdcm
2 Velocities E A med E39 lat E39 still images mitral_flowdcm medial_tdidcm lateral_tdidcm
3 Tricupid regurgitation spectral image still images trdcm
3412 Acquisition of TEE
1 Projection on LAA Left Atrial Appendage 0 45 90 135 degrees and other projections that are necessary to correctly image the entire LAA according to the investigator echocardiographer laa_0dcm laa_45dcm laa_135dcm etc
2 3D acquisition of the volume that contains LAA multi-beat-optimized 3d_LAAdcm
3 Measurement of maximum emptying velocity of LAA 1cm from the LAA ostium - at least three measurements in two different scanning angles averaged
4 Acquisition of spectral Doppler image of LAA emptying three images from two or more scanning angles still images laav_60dcm laav135dcm laav_45dcm
3413 Other modalities There are no specific acquisition requirements for cardiac CT CMR or ECG - these studies should be performed according to local standard protocols
Appendix 1 - Dictionary of tabular data
Variable CaseID Display name Case ID Type ID Compulsory Yes Categories and Units details Consecutive IDs unique for each entry
Variable PatientID Display name Patient ID Type ID Compulsory Yes Categories and Units details Consecutive ID for patients if the patient is entered to the registry more than once heshe should have the same PatientID
Variable procedure_type Display name Type of planned intervention Type Clinical Compulsory Yes Categories and Units details ablation 1 cardioversion 2 NA 3 laa_closure 4 valvular disease 5 infective endocarditis 6
Variable AF Display name Atrial fibrillation Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable AFL Display name Atrial flutter Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable arrythmia_duration Display name Paroxysmal persistent or long-standing Type Clinical Compulsory Yes Categories and Units details persistent 1 paroxysmal 2 long-standing persistent 3 NA 4
Variable Persistent_arrythmia_time Display name Time since the onset of persistent arrythmia Type Clinical Compulsory Yes Categories and Units details Time in months or days Enter 0 for paroxysmal arrythmia
Variable Persistent_arrythmia_time_unit Display name Months or days Type Clinical Compulsory Yes Categories and Units details Months 0 Days 1
Variable Disease_duration Display name Duration of AF Disease Type Clinical Compulsory Yes Categories and Units details Time approximate since the first diagnosis of atrial fibrillation
Variable Disease_duration_unit Display name Months or Years Type Clinical Compulsory Yes Categories and Units details Months 0 Years 1
Variable EHRA Display name EHRA scale Type Clinical Compulsory Yes Categories and Units details I 1 IIa 2 IIb 3 III 4 IV 5 NA 6
Variable Age Display name Age Type Clinical Compulsory Yes Categories and Units details Age in years
Variable Sex Display name Sex Type Clinical Compulsory Yes Categories and Units details Male 1 Female 2
Variable Height Display name Height Type Clinical Compulsory Yes Categories and Units details Height in cm
Variable Weight Display name Weight Type Clinical Compulsory Yes Categories and Units details Weight in kg
Variable HF_status Display name Heart failure Type Clinical Compulsory Yes Categories and Units details HFmrEF 1 HFpEF 2 HFrEF 3 No HF 4
Variable NYHA Display name NYHA scale Type Clinical Compulsory Yes Categories and Units details I 0 II 1 III 2 IV 3 No HF 4
Variable MS Display name Mitral stenosis Type Clinical Compulsory Yes Categories and Units details mild 1 moderate 2 severe 3 no MS 4
Variable MR Display name Mitral regurgitation Type Clinical Compulsory Yes Categories and Units details mild 1 moderate 2 severe 3 no MR 4
Variable AS Display name Aortic stenosis Type Clinical Compulsory Yes Categories and Units details mild 1 moderate 2 severe 3 no AS 4
Variable AR Display name Aortic regurgitation Type Clinical Compulsory Yes Categories and Units details mild 1 moderate 2 severe 3 no AR 4
Variable mitral_valve_replacement Display name Mitral valve replacement Type Clinical Compulsory Yes Categories and Units details biological 1 mechanical 2 No MVR 3
Variable aortic_valve_replacement Display name Aortic valve replacement Type Clinical Compulsory Yes Categories and Units details biological 1 mechanical 2 No AVR 3
Variable Implanatable_device Display name Presence of implantable electronic device Type Clinical Compulsory Yes Categories and Units details None 0 pacemaker 1 ICD 2 CRT-D 3 CRT-P 4 Implantable Recorder 5 S-ICD 6 Leadless pacemaker 7
Variable stroke_type Display name History of stroke Type Clinical Compulsory Yes Categories and Units details haemorrhagic stroke 1 ischaemic stroke 2 both 3 no history of stroke 4
Variable peripheral_embolus Display name History of peripheral embolism Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable revasc Display name Prior revascularisation Type Clinical Compulsory Yes Categories and Units details CABG 1 No history of revasc 2 PCI 3 PCICABG 4
Variable cad Display name Coronary Artery Disease Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable vascular_disease Display name Vascular disease Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable past_bleeding Display name History of bleeding Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable CKD Display name Chronic kidney disease Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable HT Display name Hypertension Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable DM Display name Diabetes Mellitus Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable liver_disease Display name Liver disease Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable labile_INR Display name Labile INR Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable alcohol Display name Alcohol abuse Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable smoking Display name Smoking Type Clinical Compulsory Yes Categories and Units details currently 1 in the past 2 non-smoker 3
Variable malignant_tumor Display name Malignant tumor or cancer Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0 Malignant tumor or cancer or hematologic malignant disease
Variable COPD Display name Chronic obstructive pulmonary disease Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable asthma Display name Asthma Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable hyperthyroidism Display name Hyperthyroidism Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable hypothyroidism Display name Hypothyroidism Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable LA_dimension Display name Left atrial AP dimension Type TTE Compulsory Yes Categories and Units details Value in mm
Variable LVDd Display name Left ventricular internal diameter end diastole Type TTE Compulsory Yes Categories and Units details Value in mm
Variable RVDd Display name Right ventricular internal diameter end diastole Type TTE Compulsory Yes Categories and Units details Value in mm
Variable EF_TTE Display name Left Ventricular Ejection Fraction Type TTE Compulsory Yes Categories and Units details Value in
Variable LA_area_4ch Display name Left atrial area in four-chamber view Type TTE Compulsory Yes Categories and Units details Value in cm2
Variable LA_length_4ch Display name Left atrial length in four-chamber view Type TTE Compulsory No Categories and Units details Value in cm
Variable LA_area_2ch Display name Left atrial area in two-chamber view Type TTE Compulsory No Categories and Units details Value in cm2
Variable LA_length_2ch Display name Left atrial length in two-chamber view Type TTE Compulsory No Categories and Units details Value in cm
Variable LA_volume_sp Display name Left atrial single-plane volume Type TTE Compulsory No Categories and Units details Value in cm3
Variable LA_volume Display name Left atrial biplane volume Type TTE Compulsory No Categories and Units details Value in cm3
Variable LAVI Display name Left atrial volume index Type TTE Compulsory No Categories and Units details Value in cm3m2
Variable E Display name Peak E-wave velocity Type TTE Compulsory Yes Categories and Units details Value in cms
Variable A Display name Peak A-wave velocity Type TTE Compulsory Yes Categories and Units details Value in cms
Variable Med_Eprim Display name Med E39 - Early diastolic medial mitral annulus velocity Type TTE Compulsory Yes Categories and Units details Value in cms
Variable Lat_Eprim Display name Lat E39 - Early diastolic lateral mitral annulus velocity Type TTE Compulsory Yes Categories and Units details Value in cms
Variable RA area Display name Right atrial area Type TTE Compulsory No Categories and Units details Value in cm2
Variable Act Display name Pulmonary acceleration time Type TTE Compulsory Yes Categories and Units details Value in ms
Variable lab_date Display name Lab Test Date Type Lab Tests Compulsory No Categories and Units details If blood sample was drawn during hospitalization and lab test results are entered please provide the date of lab tests
Variable BNP Display name NT-proBNP Type Lab Tests Compulsory No
Categories and Units details
Variable Fib Display name Fibrynogen Type Lab Tests Compulsory No
Categories and Units details
Variable CRP Display name C-reactive Protein Type Lab Tests Compulsory No
Categories and Units details
Variable APTT Display name Activated partial Thromboplastin Time Type Lab Tests Compulsory No
Categories and Units details
Variable INR Display name International Normalized Ratio Type Lab Tests Compulsory No
Categories and Units details
Variable Hb Display name Hemoglobin Type Lab Tests Compulsory No
Categories and Units details
Variable RDW Display name Red Cell Distribution Width Type Lab Tests Compulsory No
Categories and Units details
Variable Crea Display name Creatinine Type Lab Tests Compulsory No Categories and Units details mgdl
Variable months_anticoagulation Display name Months since initiation of anticoagulation Type Medication Compulsory Yes Categories and Units details Time in months if more than one year enter 12
Variable days_anticoagulation Display name Days since initiation of anticoagulation Type Medication Compulsory Yes Categories and Units details if lt1 month otherwise leave blank
Variable anticoagulant Display name Type of anticoagulant medication Type Medication Compulsory Yes Categories and Units details apixaban_2x5 1 rivaroxaban_20 2 dabigatran_2x150 3 acenocumarol 4 warfarin 5 apixaban_2x25 6 rivaroxaban_15 7 dabigatran_2x110 8 LVH 9 HNF 10 no anticoagulation 11
Variable days_dabigatran_temp_use Display name Temporary use of dabigatran days Type Medication Compulsory Yes Categories and Units details Explanation This is perhaps site-specific In our center we change medication to dabigatran in the periprocedural period because of access to praxbind
Variable ASA Display name intake of acetylsalicylic acid Type Medication Compulsory Yes Categories and Units details Yes 1 No 0
Variable clopidogrel Display name intake of clopidogrel Type Medication Compulsory Yes Categories and Units details Yes 1 No 0
Variable tikagrelor Display name intake of tikagrelor Type Medication Compulsory Yes Categories and Units details Yes 1 No 0
Variable prasugrel Display name intake of prasugrel Type Medication Compulsory Yes Categories and Units details Yes 1 No 0
Variable base_rythm Display name Rhythm at the time of study Type Clinical Compulsory Yes Categories and Units details SR 1 AF 1 Afl 2
Variable TEE_in_cath_lab Display name TEE performed in cath lab Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0 indicates if TEE was performed during the ablation procedure
Variable TEE_historyof_LAT Display name History of LAT in TEE Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0 indicates that the patient had TEE in the past where LAT was present
Variable TEE_historyof_LAT_date Display name Date of TEE where LAT was diagnosed in the past Type Clinical Compulsory No Categories and Units details If above is true provide date of previous TEE
Variable TEE_SEC Display name transesophageal echocardiography spontaneous echo contrast Type TEE Compulsory Yes Categories and Units details Yes 1 No 0
Variable TEE_DSEC Display name transesophageal echocardiography dense spontaneous echo contrast Type TEE Compulsory Yes Categories and Units details Yes 1 No 0
Variable TEE_LAAV Display name transesophageal echocardiography left atrial appendage flow velocity Type TEE Compulsory Yes Categories and Units details value in cms
Variable TEE_LAT Display name Presence of left atrial appendage thrombus Type TEE Compulsory Yes
Categories and Units details
Variable CT_date Display name Date of computed tomography Type Other modalities Compulsory No Categories and Units details If CT was performed date of scan
Variable CT_DICOM_available Display name Availability of CT DICOM data Type Other modalities Compulsory Yes Categories and Units details Yes 1 No 0
Variable CT_CAC_score Display name Coronary Artery Calcium Score Type Other modalities Compulsory No Categories and Units details If CAC scan was performed CAC score in Agatston Units
Variable CT_LA_Volume Display name LA Volume in CT Type Other modalities Compulsory No Categories and Units details ml only if LA volume was assessed in CT
Variable ECG_date Display name Date of ECG Type Other modalities Compulsory No
Categories and Units details
Variable ECG_dicom_available Display name Availability of ECG DICOM data Type Other modalities Compulsory No
Categories and Units details
Variable CMR_date Display name Date of Cardiac Magnetic Resonance Type Other modalities Compulsory No
Categories and Units details
Variable CMR_dicom_available Display name Availability of CMR DICOM data Type Other modalities Compulsory No
Categories and Units details
Variable ablation_type Display name Type of catheter ablation Type Ablation Compulsory No Categories and Units details Cryobaloon ablation 1 Pulsed field ablation 2 RF ablation 3 Other 4
Variable first_ablation Display name First ablation or re-do Type Ablation Compulsory No Categories and Units details Yes 1 No 0 0 indicates re-do
Variable electroanatomical_mapping Display name Type of catheter ablation Type Ablation Compulsory No Categories and Units details Yes 1 No 0 indicates if the procedure was electroanatomical map was created
Variable LVZ Display name Presence of low-voltage zones LVZ Type Ablation Compulsory No Categories and Units details Yes 1 No 0 LVZ should be measured in sinus rhythm excluding pulmonary veins preferably with multipolar catheter Threshold lt05mV on sinus rhythm lt03mV on AF
Variable LVZ_locations Display name Locations of LVZ Type Ablation Compulsory No Categories and Units details Multiple choice anterior wall posterior wall superior wall Huo T Gaspar M Pohl et al Europace 20 2018 956-962
Variable ablation targets Display name Regions of ablation energy Type Ablation Compulsory No Categories and Units details Multiple choice PVI anterior wall posterior wall superior wall
Variable fluoro_time Display name Time duration of fluoroscopy Type Ablation Compulsory No Categories and Units details Minutes
Variable DLP Display name Dose length product Type Ablation Compulsory No Categories and Units details mGycm
Variable dwell_time Display name Time in the left atrium dwell time Type Ablation Compulsory No Categories and Units details Minutes Defined as time since the catheters entered left atrium
Variable complications Display name Complications during ablation Type Ablation Compulsory No Categories and Units details if any indicate what kind
Atrial fibrillation AF is the most common cardiac arrythmia that affects 37 Europeans over 55 years old representing a major burden for the society and health systems One of the most devastating consequences of AF is ischemic stroke often caused by embolization of cerebral arteries with a left atrial appendage thrombus LAT which can form in left atrial appendage in the presence of AF As it has little contractility on its own emptying and filling of left atrial appendage relies on the function of the left ventricle and the left atrium
AF as well as atrial flutter promote the formation of LAT and are therefore associated with an increased risk of thromboembolic events The mechanism of stroke is complex but embolization with LAT accounts for the majority of events and it can be triggered by sinus rhythm restoration through procedures commonly performed in patients with AF - cardioversion or catheter ablation Therefore cardioversion and catheter ablation in the presence of LAT are contraindicated
Transoesophageal echocardiography TEE is considered the modality of choice to detect LAT with high sensitivity and specificity and is currently recommended before cardioversion or catheter ablation as an alternative to a 3-week course of oral anticoagulation Current guidelines however leave room for an individual decision to either perform or not perform TEE before catheter ablation or cardioversion in a chronically anticoagulated patient but suggest no tools to assess the risk of LAT To address this unmet clinical need we have previously shown that by combining clinical data and measurements from transthoracic echocardiography in a machine-learning model it is possible to predict the risk of LAT formation Importantly our results indicated that TTE-derived measurements played the greatest role in predicting LAT
Despite significant advancements in interventional technologies the selection of appropriate therapeutic methods and perioperative procedures remains a significant challenge Patients eligible for interventional procedures related to AF often undergo numerous diagnostic tests including computed tomography of the heart transoesophageal and transthoracic echocardiography electrocardiography EKG and electroanatomic mapping during the ablation procedure Non-invasive multimodal imaging plays central role in the peri-ablation period informing important therapeutic decisions and facilitating the procedure The essence of this project is the prospective collection of high-quality imaging data from these multiple modalities and clinical data which will allow for a better understanding of the relationships between anatomy hemodynamic function and clinical observation in patients with AF in the future Ultimately the data might serve for the development of tools which could efficiently predict the risk of LAT by means of less invasive and cheaper approaches than the ones which are currently used The resulting multimodal database will also form a foundation for future studies targeted at informing therapeutic decisions in patients undergoing catheter ablation of AF
2 Study Objectives
21 Main objective To create a multimodal multicentre registry of clinical and imaging data to develop predictive models based on state-of the art artificial intelligence to support the diagnostic and therapeutic process for patients undergoing AF catheter ablation and cardioversion
22 Specific objectives
221 Specific Aim 1 Creation of artificial intelligence-based models to predict the risk of formation of left atrial appendage thrombus and estimate the left atrial appendage emptying velocity obtained from transoesophageal echocardiography based on the analysis of transthoracic echocardiographic images and clinical data
222 Specific Aim 2 Assessment of inter-reader and intra-reader agreement in the clinical interpretation of left atrial appendage images and left atrial appendage thrombus diagnosis in transoesophageal echocardiography
223 Specific Aim 3 Development of models that fuse information from multiple modalities for instance from transthoracic echocardiography and cardiac CT to provide better prognosis and guide therapeutic decisions in patients with atrial fibrillation
224 Specific Aim 4 Comparison of the effectiveness of different methods of imaging the left atrium in predicting thromboembolic events
225 Specific Aim 5 Creation of a high-quality multicentre imaging database for additional future auxillary nalyses and studies
3 Study Methodology
To maximize the amount of collected data the study allows both retrospective and prospective data collection The scope of collected data is the same in retrospective and prospective collection with certain data types being optional and subject to availability
31 Inclusion criteria
Patients with
history of atrial fibrillation
who are undergoing medically justified transoesophageal echocardiography to assess the presence of left atrial appendage thrombus before catheter ablation of atrial fibrillation including patients who had transoesophageal echocardiography during the ablation procedure OR
who undergo catheter ablation without prior transoesophageal echocardiography if the center also collects additional imaging data listed in point 25 below 32 Exclusion criteria
Age lt 18 years old
33 33 Types of collected data
Data type Clinical data Compulsory or optional Includes compulsory and optional fields Format Tabular collected using a dedicated eCRF Additional remarks The detailed list of fields with possible values is shown in Appendix 1
Data type TTE Compulsory or optional Compulsory Format DICOM Additional remarks Recorded before TEE preferably on the same day In case of retrospective data TTE and TEE acquired within 72h
Data type TEE Compulsory or optional Compulsory if the patient had TEE Format DICOM
Additional remarks
Data type Cardiac CT Compulsory or optional Optional Format DICOM Additional remarks Contrast enhanced cardiac CT before ablation procedure Can be a study performed for EP planning or for CAD diagnostics Any study performed before the ablation regardless of timing can be used
Data type Non-contrast Cardiac CT Compulsory or optional Optional Format DICOM Additional remarks Non-contrast chest CT Preferred is ECG-gated calcium scoring CT reconstructed with thin slices preferably 05mm
Data type Cardiac Magnetic Resonance CMR Compulsory or optional Optional Format DICOM
Additional remarks
Data type Digitalised Electrocardiogram Compulsory or optional Optional Format DICOM or pdf Additional remarks Performed on the day of the catheter ablation or cardioversion or day before
Data type Electroanatomical map Compulsory or optional Optional Format Proprietary Additional remarks Not to be transferred but only stored locally in the participating center for possible ancillary studies
Data type Follow-up for MACE Compulsory or optional Optional Format Event date Additional remarks Depending on the local regulations and possibility the follow-up data for all-cause mortality stroke myocardial infarction onset or worsening of heart failure will be obtained based on ICD-9 and ICD 10 codes from the national health insurance databases Alternatively data can be obtained by telephone interview
Data type Follow-up for AF Compulsory or optional Optional Format Event date Additional remarks Depending on the local availability of follow-up data for AF recurrence
34 Guidelines for data acquisition
341 Guidelines for Acquisition of Transthoracic and Transesophageal Echocardiography
For prospective collection the TEE and TEE should be performed ideally in the same day TTE directly before TEE For the retrospective cohort TTE can be acquired up to 3 days before TEE as long as there were no important changes in patients condition during this period ie clinical worsening change of rhythm heart rate etc
ECG electrodes should be connected for both TTE and TEE not compulsory for retrospective data
The acquisition length should be set to 5 seconds set the start acquisition at the moment when acquire button is pressed to minimise unwanted movement For retrospective data shorter clips are acceptable
3411 Acquisition of TTE filenames are given in brackets
1 Four-chamber apical projection 4chdcm
2 Two-chamber apical projection 2chdcm
3 Three-chamber apical projection 3chdcm
4 Four-chamber apical projection - optimized for LA 4chLAdcm
5 Two-chamber apical projection - optimized for LA 2chLAdcm
6 3D full volume preferably acquired from 4 or more heart cycles 3d_ttedcm The projections must encompass the entire heart including the atria Measurements to be performed at site if impossible some of these measurements can also be performed by the coordinating site
-- --
1 Cardiac chamber dimensions PLAX plaxdcm
2 Velocities E A med E39 lat E39 still images mitral_flowdcm medial_tdidcm lateral_tdidcm
3 Tricupid regurgitation spectral image still images trdcm
3412 Acquisition of TEE
1 Projection on LAA Left Atrial Appendage 0 45 90 135 degrees and other projections that are necessary to correctly image the entire LAA according to the investigator echocardiographer laa_0dcm laa_45dcm laa_135dcm etc
2 3D acquisition of the volume that contains LAA multi-beat-optimized 3d_LAAdcm
3 Measurement of maximum emptying velocity of LAA 1cm from the LAA ostium - at least three measurements in two different scanning angles averaged
4 Acquisition of spectral Doppler image of LAA emptying three images from two or more scanning angles still images laav_60dcm laav135dcm laav_45dcm
3413 Other modalities There are no specific acquisition requirements for cardiac CT CMR or ECG - these studies should be performed according to local standard protocols
Appendix 1 - Dictionary of tabular data
Variable CaseID Display name Case ID Type ID Compulsory Yes Categories and Units details Consecutive IDs unique for each entry
Variable PatientID Display name Patient ID Type ID Compulsory Yes Categories and Units details Consecutive ID for patients if the patient is entered to the registry more than once heshe should have the same PatientID
Variable procedure_type Display name Type of planned intervention Type Clinical Compulsory Yes Categories and Units details ablation 1 cardioversion 2 NA 3 laa_closure 4 valvular disease 5 infective endocarditis 6
Variable AF Display name Atrial fibrillation Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable AFL Display name Atrial flutter Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable arrythmia_duration Display name Paroxysmal persistent or long-standing Type Clinical Compulsory Yes Categories and Units details persistent 1 paroxysmal 2 long-standing persistent 3 NA 4
Variable Persistent_arrythmia_time Display name Time since the onset of persistent arrythmia Type Clinical Compulsory Yes Categories and Units details Time in months or days Enter 0 for paroxysmal arrythmia
Variable Persistent_arrythmia_time_unit Display name Months or days Type Clinical Compulsory Yes Categories and Units details Months 0 Days 1
Variable Disease_duration Display name Duration of AF Disease Type Clinical Compulsory Yes Categories and Units details Time approximate since the first diagnosis of atrial fibrillation
Variable Disease_duration_unit Display name Months or Years Type Clinical Compulsory Yes Categories and Units details Months 0 Years 1
Variable EHRA Display name EHRA scale Type Clinical Compulsory Yes Categories and Units details I 1 IIa 2 IIb 3 III 4 IV 5 NA 6
Variable Age Display name Age Type Clinical Compulsory Yes Categories and Units details Age in years
Variable Sex Display name Sex Type Clinical Compulsory Yes Categories and Units details Male 1 Female 2
Variable Height Display name Height Type Clinical Compulsory Yes Categories and Units details Height in cm
Variable Weight Display name Weight Type Clinical Compulsory Yes Categories and Units details Weight in kg
Variable HF_status Display name Heart failure Type Clinical Compulsory Yes Categories and Units details HFmrEF 1 HFpEF 2 HFrEF 3 No HF 4
Variable NYHA Display name NYHA scale Type Clinical Compulsory Yes Categories and Units details I 0 II 1 III 2 IV 3 No HF 4
Variable MS Display name Mitral stenosis Type Clinical Compulsory Yes Categories and Units details mild 1 moderate 2 severe 3 no MS 4
Variable MR Display name Mitral regurgitation Type Clinical Compulsory Yes Categories and Units details mild 1 moderate 2 severe 3 no MR 4
Variable AS Display name Aortic stenosis Type Clinical Compulsory Yes Categories and Units details mild 1 moderate 2 severe 3 no AS 4
Variable AR Display name Aortic regurgitation Type Clinical Compulsory Yes Categories and Units details mild 1 moderate 2 severe 3 no AR 4
Variable mitral_valve_replacement Display name Mitral valve replacement Type Clinical Compulsory Yes Categories and Units details biological 1 mechanical 2 No MVR 3
Variable aortic_valve_replacement Display name Aortic valve replacement Type Clinical Compulsory Yes Categories and Units details biological 1 mechanical 2 No AVR 3
Variable Implanatable_device Display name Presence of implantable electronic device Type Clinical Compulsory Yes Categories and Units details None 0 pacemaker 1 ICD 2 CRT-D 3 CRT-P 4 Implantable Recorder 5 S-ICD 6 Leadless pacemaker 7
Variable stroke_type Display name History of stroke Type Clinical Compulsory Yes Categories and Units details haemorrhagic stroke 1 ischaemic stroke 2 both 3 no history of stroke 4
Variable peripheral_embolus Display name History of peripheral embolism Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable revasc Display name Prior revascularisation Type Clinical Compulsory Yes Categories and Units details CABG 1 No history of revasc 2 PCI 3 PCICABG 4
Variable cad Display name Coronary Artery Disease Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable vascular_disease Display name Vascular disease Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable past_bleeding Display name History of bleeding Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable CKD Display name Chronic kidney disease Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable HT Display name Hypertension Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable DM Display name Diabetes Mellitus Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable liver_disease Display name Liver disease Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable labile_INR Display name Labile INR Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable alcohol Display name Alcohol abuse Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable smoking Display name Smoking Type Clinical Compulsory Yes Categories and Units details currently 1 in the past 2 non-smoker 3
Variable malignant_tumor Display name Malignant tumor or cancer Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0 Malignant tumor or cancer or hematologic malignant disease
Variable COPD Display name Chronic obstructive pulmonary disease Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable asthma Display name Asthma Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable hyperthyroidism Display name Hyperthyroidism Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable hypothyroidism Display name Hypothyroidism Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0
Variable LA_dimension Display name Left atrial AP dimension Type TTE Compulsory Yes Categories and Units details Value in mm
Variable LVDd Display name Left ventricular internal diameter end diastole Type TTE Compulsory Yes Categories and Units details Value in mm
Variable RVDd Display name Right ventricular internal diameter end diastole Type TTE Compulsory Yes Categories and Units details Value in mm
Variable EF_TTE Display name Left Ventricular Ejection Fraction Type TTE Compulsory Yes Categories and Units details Value in
Variable LA_area_4ch Display name Left atrial area in four-chamber view Type TTE Compulsory Yes Categories and Units details Value in cm2
Variable LA_length_4ch Display name Left atrial length in four-chamber view Type TTE Compulsory No Categories and Units details Value in cm
Variable LA_area_2ch Display name Left atrial area in two-chamber view Type TTE Compulsory No Categories and Units details Value in cm2
Variable LA_length_2ch Display name Left atrial length in two-chamber view Type TTE Compulsory No Categories and Units details Value in cm
Variable LA_volume_sp Display name Left atrial single-plane volume Type TTE Compulsory No Categories and Units details Value in cm3
Variable LA_volume Display name Left atrial biplane volume Type TTE Compulsory No Categories and Units details Value in cm3
Variable LAVI Display name Left atrial volume index Type TTE Compulsory No Categories and Units details Value in cm3m2
Variable E Display name Peak E-wave velocity Type TTE Compulsory Yes Categories and Units details Value in cms
Variable A Display name Peak A-wave velocity Type TTE Compulsory Yes Categories and Units details Value in cms
Variable Med_Eprim Display name Med E39 - Early diastolic medial mitral annulus velocity Type TTE Compulsory Yes Categories and Units details Value in cms
Variable Lat_Eprim Display name Lat E39 - Early diastolic lateral mitral annulus velocity Type TTE Compulsory Yes Categories and Units details Value in cms
Variable RA area Display name Right atrial area Type TTE Compulsory No Categories and Units details Value in cm2
Variable Act Display name Pulmonary acceleration time Type TTE Compulsory Yes Categories and Units details Value in ms
Variable lab_date Display name Lab Test Date Type Lab Tests Compulsory No Categories and Units details If blood sample was drawn during hospitalization and lab test results are entered please provide the date of lab tests
Variable BNP Display name NT-proBNP Type Lab Tests Compulsory No
Categories and Units details
Variable Fib Display name Fibrynogen Type Lab Tests Compulsory No
Categories and Units details
Variable CRP Display name C-reactive Protein Type Lab Tests Compulsory No
Categories and Units details
Variable APTT Display name Activated partial Thromboplastin Time Type Lab Tests Compulsory No
Categories and Units details
Variable INR Display name International Normalized Ratio Type Lab Tests Compulsory No
Categories and Units details
Variable Hb Display name Hemoglobin Type Lab Tests Compulsory No
Categories and Units details
Variable RDW Display name Red Cell Distribution Width Type Lab Tests Compulsory No
Categories and Units details
Variable Crea Display name Creatinine Type Lab Tests Compulsory No Categories and Units details mgdl
Variable months_anticoagulation Display name Months since initiation of anticoagulation Type Medication Compulsory Yes Categories and Units details Time in months if more than one year enter 12
Variable days_anticoagulation Display name Days since initiation of anticoagulation Type Medication Compulsory Yes Categories and Units details if lt1 month otherwise leave blank
Variable anticoagulant Display name Type of anticoagulant medication Type Medication Compulsory Yes Categories and Units details apixaban_2x5 1 rivaroxaban_20 2 dabigatran_2x150 3 acenocumarol 4 warfarin 5 apixaban_2x25 6 rivaroxaban_15 7 dabigatran_2x110 8 LVH 9 HNF 10 no anticoagulation 11
Variable days_dabigatran_temp_use Display name Temporary use of dabigatran days Type Medication Compulsory Yes Categories and Units details Explanation This is perhaps site-specific In our center we change medication to dabigatran in the periprocedural period because of access to praxbind
Variable ASA Display name intake of acetylsalicylic acid Type Medication Compulsory Yes Categories and Units details Yes 1 No 0
Variable clopidogrel Display name intake of clopidogrel Type Medication Compulsory Yes Categories and Units details Yes 1 No 0
Variable tikagrelor Display name intake of tikagrelor Type Medication Compulsory Yes Categories and Units details Yes 1 No 0
Variable prasugrel Display name intake of prasugrel Type Medication Compulsory Yes Categories and Units details Yes 1 No 0
Variable base_rythm Display name Rhythm at the time of study Type Clinical Compulsory Yes Categories and Units details SR 1 AF 1 Afl 2
Variable TEE_in_cath_lab Display name TEE performed in cath lab Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0 indicates if TEE was performed during the ablation procedure
Variable TEE_historyof_LAT Display name History of LAT in TEE Type Clinical Compulsory Yes Categories and Units details Yes 1 No 0 indicates that the patient had TEE in the past where LAT was present
Variable TEE_historyof_LAT_date Display name Date of TEE where LAT was diagnosed in the past Type Clinical Compulsory No Categories and Units details If above is true provide date of previous TEE
Variable TEE_SEC Display name transesophageal echocardiography spontaneous echo contrast Type TEE Compulsory Yes Categories and Units details Yes 1 No 0
Variable TEE_DSEC Display name transesophageal echocardiography dense spontaneous echo contrast Type TEE Compulsory Yes Categories and Units details Yes 1 No 0
Variable TEE_LAAV Display name transesophageal echocardiography left atrial appendage flow velocity Type TEE Compulsory Yes Categories and Units details value in cms
Variable TEE_LAT Display name Presence of left atrial appendage thrombus Type TEE Compulsory Yes
Categories and Units details
Variable CT_date Display name Date of computed tomography Type Other modalities Compulsory No Categories and Units details If CT was performed date of scan
Variable CT_DICOM_available Display name Availability of CT DICOM data Type Other modalities Compulsory Yes Categories and Units details Yes 1 No 0
Variable CT_CAC_score Display name Coronary Artery Calcium Score Type Other modalities Compulsory No Categories and Units details If CAC scan was performed CAC score in Agatston Units
Variable CT_LA_Volume Display name LA Volume in CT Type Other modalities Compulsory No Categories and Units details ml only if LA volume was assessed in CT
Variable ECG_date Display name Date of ECG Type Other modalities Compulsory No
Categories and Units details
Variable ECG_dicom_available Display name Availability of ECG DICOM data Type Other modalities Compulsory No
Categories and Units details
Variable CMR_date Display name Date of Cardiac Magnetic Resonance Type Other modalities Compulsory No
Categories and Units details
Variable CMR_dicom_available Display name Availability of CMR DICOM data Type Other modalities Compulsory No
Categories and Units details
Variable ablation_type Display name Type of catheter ablation Type Ablation Compulsory No Categories and Units details Cryobaloon ablation 1 Pulsed field ablation 2 RF ablation 3 Other 4
Variable first_ablation Display name First ablation or re-do Type Ablation Compulsory No Categories and Units details Yes 1 No 0 0 indicates re-do
Variable electroanatomical_mapping Display name Type of catheter ablation Type Ablation Compulsory No Categories and Units details Yes 1 No 0 indicates if the procedure was electroanatomical map was created
Variable LVZ Display name Presence of low-voltage zones LVZ Type Ablation Compulsory No Categories and Units details Yes 1 No 0 LVZ should be measured in sinus rhythm excluding pulmonary veins preferably with multipolar catheter Threshold lt05mV on sinus rhythm lt03mV on AF
Variable LVZ_locations Display name Locations of LVZ Type Ablation Compulsory No Categories and Units details Multiple choice anterior wall posterior wall superior wall Huo T Gaspar M Pohl et al Europace 20 2018 956-962
Variable ablation targets Display name Regions of ablation energy Type Ablation Compulsory No Categories and Units details Multiple choice PVI anterior wall posterior wall superior wall
Variable fluoro_time Display name Time duration of fluoroscopy Type Ablation Compulsory No Categories and Units details Minutes
Variable DLP Display name Dose length product Type Ablation Compulsory No Categories and Units details mGycm
Variable dwell_time Display name Time in the left atrium dwell time Type Ablation Compulsory No Categories and Units details Minutes Defined as time since the catheters entered left atrium
Variable complications Display name Complications during ablation Type Ablation Compulsory No Categories and Units details if any indicate what kind
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None