Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
Study NCT ID:
NCT06701292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-22
First Post:
2024-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Precision Ablation for Pulmonary Vein Isolation: Targeting Pulmonary Vein Myocardial Sleeves (PVMS) with Omnipolar Mapping Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2024-11-17', 'studyFirstSubmitQcDate': '2024-11-19', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of minutes taken from Initial puncture to transseptal access', 'timeFrame': 'From time of Initial puncture to time of transseptal access (an average of 10 minutes)'}, {'measure': 'Number of minutes taken from transseptal access to left atrium 3D map completion', 'timeFrame': 'From time of transseptal access to time of left atrium 3D map completion (an average of 15 minutes)'}, {'measure': 'Number of minutes taken from left atrium 3D map completion to when all pulmonary veins are isolated', 'timeFrame': 'From time of left atrium 3D map completion to time when all pulmonary veins are isolated (an average of 30-60 minutes)'}, {'measure': 'Number of minutes with catheters in the left atrium', 'timeFrame': 'from time catheters are inserted to time catheters are removed (an average of 45-80 minutes)'}, {'measure': 'Time from initial puncture till all sheaths removed', 'timeFrame': 'From time of initial puncture to time when all sheaths removed (an average of 90 minutes)'}, {'measure': 'Total time of radiofrequency applications in seconds', 'timeFrame': 'from start of radiofrequency application to end of radiofrequency applications(an average of 300-900 seconds)'}, {'measure': 'Number of radiofrequency applications used', 'timeFrame': 'end of procedure (an average of 1.5 hours after baseline)'}], 'secondaryOutcomes': [{'measure': 'Day and time to first recurrence of any documented atrial arrhythmias', 'timeFrame': 'an average of 91 days after catheter ablation', 'description': 'This will be remotely monitored with the Internal loop recorder (ILR) monthly and in clinic every 3 months until the end of the follow up'}, {'measure': 'Time in sinus rhythm as assessed by the percentage of time that the patient remains in sinus rhythm during the pre-established monitoring', 'timeFrame': '3 months follow up', 'description': 'This will be remotely monitored with the ILR monthly and in clinic every 3 months until the end of the follow up'}, {'measure': 'Time in sinus rhythm as assessed by the percentage of time that the patient remains in sinus rhythm during the pre-established monitoring', 'timeFrame': '6 months follow up', 'description': 'This will be remotely monitored with the ILR monthly and in clinic every 3 months until the end of the follow up'}, {'measure': 'Number of Procedure-related complications', 'timeFrame': 'end of study (6 months after procedure)', 'description': 'Complications include Atrio-esophageal fistula, Stroke or transient ischemic attack (TIA), Pericardial effusion/cardiac tamponade, PV stenosis , Vascular access-related complications , Diaphragmatic paralysis , other severe complications or other non-severe complications 0.37%'}, {'measure': 'Number of deaths', 'timeFrame': 'end of study (6 months after procedure)'}, {'measure': 'Total radiation exposure dose', 'timeFrame': 'end of procedure (about 1.5 hours after start of procedure)'}, {'measure': 'Number of participants that need a repeat catheter ablation procedure due to documented recurrence of symptomatic atrial arrhythmia', 'timeFrame': 'end of procedure till 6 months after procedure'}, {'measure': 'Number of occurrences of any AF (symptomatic or asymptomatic) documented on ECG or ILR', 'timeFrame': 'during the first 90 days following catheter ablation.'}, {'measure': 'Number of participants that visit the emergency room', 'timeFrame': 'end of procedure till 6 months after procedure'}, {'measure': 'Number of participants that are hospitalized', 'timeFrame': 'end of procedure till 6 months after procedure'}, {'measure': 'Number of incidences of stroke', 'timeFrame': 'end of procedure till 6 months after procedure'}, {'measure': 'Change in quality of life as assessed by the Quality of Life (EQ-5D-5L) assessment', 'timeFrame': 'Baseline, 6 months after procedure', 'description': 'This is a 6 item questionnaire and the first 5 questions are each is scored from 1(no problem)-5(unable to) for a maximum score of 25, higher number indicating worse outcome. The 6th question is score on likert scale from 0(worst health you can imagine)-100(best health you can imagine), higher score indicating worse outcome'}, {'measure': 'Number of participants that show a need for electrical cardioversion', 'timeFrame': 'end of procedure till 6 months after procedure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Ablation', 'symptomatic paroxysmal Atrial Fibrillation'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare procedural times and Radiofrequency (RF)applications required for Pulmonary vein myocardial sleeves targeted pulmonary vein ablation (PVS-PVI) , to compare the efficacy of PVS-PVI , to compare the safety of PVS-PVI and to assess other clinical outcomes of PVS-PVI in individuals with symptomatic paroxysmal Atrial fibrillation (AF) using Omnipolar Technology with conventional Wide area circumferential ablation (WACA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic paroxysmal AF refractory to at least one Class I or Class III antiarrhythmic medication, intolerance to antiarrhythmic medications, or a preference to not trial antiarrhythmic medications\n* A minimum of one documented AF episode via 12-lead ECG, Holter monitor, or loop recorder\n* Capability to provide informed consent\n\nExclusion Criteria:\n\n* Persistent or permanent AF\n* Prior history of catheter or surgical ablation for AF or left atrial ablation for atypical flutter\n* Reversible causes of AF\n* Congenital heart disease\n* Significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation)\n* Pregnancy\n* Known presence of intracardiac thrombus\n* Systemic oral anticoagulation therapy contraindicated, including a history of heparin-induced thrombocytopenia\n* Broad vortex-like connections and no clear PVMS to be targeted'}, 'identificationModule': {'nctId': 'NCT06701292', 'acronym': 'PVS-PVI', 'briefTitle': 'Precision Ablation for Pulmonary Vein Isolation: Targeting Pulmonary Vein Myocardial Sleeves (PVMS) with Omnipolar Mapping Technology', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Precision Ablation for Pulmonary Vein Isolation: Targeting Pulmonary Vein Myocardial Sleeves with Omnipolar Mapping Technology - a Randomized Pilot Trial', 'orgStudyIdInfo': {'id': 'HSC-MS-24-0150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PVS-PVI', 'interventionNames': ['Device: PVS-PVI targeted ablation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'WACA', 'interventionNames': ['Device: Wide area circumferential ablation (WACA)']}], 'interventions': [{'name': 'PVS-PVI targeted ablation', 'type': 'DEVICE', 'description': 'Omnipolar technology will be used to analyze all PVs and delineate the PVMS. Once identified, PVMS will be marked and described in a clockface fashion using a lateral view of the vein.Ablation will target the PVMS using the same power and force parameters as described for the WACA procedure. Effective ablation lesions and distance between ablation spots will be represented in the same manner too. Lesions should cover at least 5 mm outside the PVMS delineation on both PVMS borders of each myocardial sleeve. PVI will be demonstrated with the same technique described in the WACA procedure.\n\nThe PVI will be verified for each vein 10 minutes after the initial achievement of PVI.', 'armGroupLabels': ['PVS-PVI']}, {'name': 'Wide area circumferential ablation (WACA)', 'type': 'DEVICE', 'description': 'After generating the 3D electroanatomical map of the heart to understand where treatment needs to be applied,using a tool called radiofrequency (RF) ablation, small burns will be made around the veins to block abnormal electrical signals. Each burn is applied with up to 50 watts of power and lasts up to 10 seconds.The ablation tool will press down with a force of around 10-20 grams.The mapping system (NAVX software) shows the burns on the 3D map', 'armGroupLabels': ['WACA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Ramesh Hariharan, D, MRCP, FACC, FHRS', 'role': 'CONTACT', 'email': 'Ramesh.Hariharan@uth.tmc.edu', 'phone': '(713) 500-6521'}, {'name': 'Alejandro V Margenat', 'role': 'CONTACT', 'email': 'Alejandro.VidalMargenat@uth.tmc.edu', 'phone': '(713) 486-1625'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Ramesh Hariharan, D, MRCP, FACC, FHRS', 'role': 'CONTACT', 'email': 'Ramesh.Hariharan@uth.tmc.edu', 'phone': '(713) 500-6521'}, {'name': 'Alejandro V Margenat', 'role': 'CONTACT', 'email': 'Alejandro.VidalMargenat@uth.tmc.edu', 'phone': '(713) 486-1625'}], 'overallOfficials': [{'name': 'Ramesh Hariharan, D, MRCP,FACC, FHRS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ramesh Hariharan', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}