Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05907863
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2023-06-08
Brief Title:
Intracardiac Echocardiography Guided vs Electroanatomical Mapping System Guided Slow Pathway Ablation in Patients With Atrioventricular Nodal Reentrant Tachycardia
Sponsor:
University of Pecs
Organization:
University of Pecs
Study Overview
Official Title:
Intracardiac Echocardiography Guided vs Electroanatomical Mapping System Guided Slow Pathway Ablation in Patients With Atrioventricular Nodal Reentrant Tachycardia
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study protocol
To prepare for the electrophysiologic study antiarrhythmic drugs were discontinued at least five half-lives before the procedure and were under conscious sedation using midazolam fentanyl while fasting
ICE-guided ablation group In patients randomized to ICE-guided ablation group catheter placement was initially performed using fluoroscopy guidance after local anesthesia A decapolar steerable catheter was placed in the coronary sinus CS a quadripolar electrode catheter was positioned in the right ventricular apex and an ablation catheter was inserted to record the His bundle electrogram Twelve-lead electrocardiogram and intracardiac electrograms were recorded and saved on a digital recording system using a band pass filter of 30 to 500 Hz Electrical stimulation techniques were used to test atrioventricular nodal conduction and induce AVNRT with the S2 coupling interval being gradually shortened after each drive-train until tachycardia was induced AV conduction block occurred or the atrial refractory period was reached If tachycardia was not inducible isoprenaline infusion was given to increase the heart rate by at least 20 and the same stimulation protocol was repeated during both the infusion and washout phases The diagnosis of AVNRT was made using established electrophysiologic criteria and pacing maneuvers This involved assessing the A-H-V response after ventricular overdrive pacing with an SA-VA interval greater than 85 ms and a corrected postpacing interval minus tachycardia cycle length greater than 110 ms
After confirmation of the diagnosis of AVNRT through the diagnostic EP study the quadripolar electrode catheter was removed and replaced with an 8F ICE catheter for mapping and SP ablation The echo-transducer was positioned in the low right atrium at the 6 oclock position and rotated clockwise towards the septum to allow for visualization of the anatomic landmarks The proximity of the ablation catheter to the compact AV node was determined by the distance from the aortic valve which marks the recording site of a proximal His potential In cases of ineffective ablation the catheter was moved closer to the aortic valve but always maintaining a distance of at least 05 cm and RF application was attempted again RF energy was delivered starting just below the CS with a power output of 30 W and a preset temperature of 55C Effective applications were continued for 30 to 60 s and considered successful when junctional rhythm appeared RF application was immediately halted if there was catheter displacement sudden impedance rise prolongation of PR interval anterograde AV or retrograde VA block
Electroanatomical mapping system -guided ablation group An ablation catheter was inserted into the heart to create an anatomical map by CARTO of the right atrium after local anesthesia and the location of the His bundle was tagged Decapolar and quadripolar diagnostic catheters were positioned thereafter into appropriate position as described above After confirming the diagnosis of AVNRT mapping of the slow pathway was started by NAVISTAR catheter guided by EAMS and aiming at an atrial-to-ventricular electrogram amplitude ratio of 13-15 If the ablation endpoint was not reached after 8 radiofrequency RF applications patients in the EMAS-guided ablation group were allowed to crossover to an ICE-guided procedure
The ablation procedure was deemed successful if following a 20-minute waiting period the arrhythmia failed to be induced and there were no instances of more than one echo beat observed both in the presence and absence of isoprenaline
The procedure time was measured from the initial femoral puncture until the withdrawal of the catheters The mapping plus ablation time was calculated from the start of the SP mapping until the end of the last attempted ablation Fluoroscopy time radiation dose and dose-area product DAP were automatically recorded by the fluoroscopy system The ablation data including the total number of RF applications sum of delivered RF energy in Watts and the total ablation time in seconds were calculated and stored by the EP recording system CardioLab GE Healthcare
To prepare for the electrophysiologic study antiarrhythmic drugs were discontinued at least five half-lives before the procedure and were under conscious sedation using midazolam fentanyl while fasting
ICE-guided ablation group In patients randomized to ICE-guided ablation group catheter placement was initially performed using fluoroscopy guidance after local anesthesia A decapolar steerable catheter was placed in the coronary sinus CS a quadripolar electrode catheter was positioned in the right ventricular apex and an ablation catheter was inserted to record the His bundle electrogram Twelve-lead electrocardiogram and intracardiac electrograms were recorded and saved on a digital recording system using a band pass filter of 30 to 500 Hz Electrical stimulation techniques were used to test atrioventricular nodal conduction and induce AVNRT with the S2 coupling interval being gradually shortened after each drive-train until tachycardia was induced AV conduction block occurred or the atrial refractory period was reached If tachycardia was not inducible isoprenaline infusion was given to increase the heart rate by at least 20 and the same stimulation protocol was repeated during both the infusion and washout phases The diagnosis of AVNRT was made using established electrophysiologic criteria and pacing maneuvers This involved assessing the A-H-V response after ventricular overdrive pacing with an SA-VA interval greater than 85 ms and a corrected postpacing interval minus tachycardia cycle length greater than 110 ms
After confirmation of the diagnosis of AVNRT through the diagnostic EP study the quadripolar electrode catheter was removed and replaced with an 8F ICE catheter for mapping and SP ablation The echo-transducer was positioned in the low right atrium at the 6 oclock position and rotated clockwise towards the septum to allow for visualization of the anatomic landmarks The proximity of the ablation catheter to the compact AV node was determined by the distance from the aortic valve which marks the recording site of a proximal His potential In cases of ineffective ablation the catheter was moved closer to the aortic valve but always maintaining a distance of at least 05 cm and RF application was attempted again RF energy was delivered starting just below the CS with a power output of 30 W and a preset temperature of 55C Effective applications were continued for 30 to 60 s and considered successful when junctional rhythm appeared RF application was immediately halted if there was catheter displacement sudden impedance rise prolongation of PR interval anterograde AV or retrograde VA block
Electroanatomical mapping system -guided ablation group An ablation catheter was inserted into the heart to create an anatomical map by CARTO of the right atrium after local anesthesia and the location of the His bundle was tagged Decapolar and quadripolar diagnostic catheters were positioned thereafter into appropriate position as described above After confirming the diagnosis of AVNRT mapping of the slow pathway was started by NAVISTAR catheter guided by EAMS and aiming at an atrial-to-ventricular electrogram amplitude ratio of 13-15 If the ablation endpoint was not reached after 8 radiofrequency RF applications patients in the EMAS-guided ablation group were allowed to crossover to an ICE-guided procedure
The ablation procedure was deemed successful if following a 20-minute waiting period the arrhythmia failed to be induced and there were no instances of more than one echo beat observed both in the presence and absence of isoprenaline
The procedure time was measured from the initial femoral puncture until the withdrawal of the catheters The mapping plus ablation time was calculated from the start of the SP mapping until the end of the last attempted ablation Fluoroscopy time radiation dose and dose-area product DAP were automatically recorded by the fluoroscopy system The ablation data including the total number of RF applications sum of delivered RF energy in Watts and the total ablation time in seconds were calculated and stored by the EP recording system CardioLab GE Healthcare
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None