Comparison of Two Pulmonary Vein Ablation Techniques for Persistent AF

Status Recruiting

Clinical Trial Summary

Investigator initiated, randomized controlled trial of two radiofrequency (RF)ablation protocols currently performed in the electrophysiology lab, but have not been studied prospectively to identify which, if either technique, is superior for individuals with persistent atrial fibrillation (AF). Two-hundred subjects will be consecutively enrolled and randomized to either pulmonary vein isolation only or pulmonary vein isolation plus posterior left atrial wall isolation

Clinical Trial Description

Atrial fibrillation, the most common type of cardiac arrhythmia in clinical practice, affects approximately 2.7 million U.S. adults. Percutaneous catheter ablation is an effective treatment option for individuals with persistent AF. Pulmonary vein isolation (PVI) has emerged as the gold standard for paroxysmal AF with excellent success rates, however, individuals with persistent AF procedural efficacy from pulmonary vein isolation is not optimal. Therefore, improved ablation strategies for these individuals are needed. This randomized controlled trial will compare two radiofrequency ablation strategies, PVI alone and pulmonary vein isolation plus left posterior atrial wall (LPAW) isolation in individuals with persistent AF. Both strategies are currently used to treat persistent AF, but no randomized controlled trial ahs been conducted to investigate which strategy is more efficacious. Two-hundred subjects will be randomized into groups of 50 to undergo a radiofrequency ablation procedure for AF. For group 1, a series of radiofrequency applications will be delivered around both sets of pulmonary veins. For group 2, a series of radiofrequency applications will be delivered around both sets of pulmonary veins and along a roof and low posterior line of the left atrial wall. All subjects will be followed at 1 month, 3 months, 6 months, and 1 year post ablation. If indicated, antiarrhythmic drugs will be discontinued. For the first month, subjects will receive a continuously recording electrocardiogram heart card to monitor for AF, and then two-week ambulatory monitors at 3 months and one year post ablation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03295422
Study type	Interventional
Source	Sequoia Hospital
Contact	Christopher E Woods, MD, PhD
Phone	650-652-8600
Email	WoodC@sutterhealth.org
Status	Recruiting
Phase	N/A
Start date	August 25, 2017
Completion date	December 31, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05970120` - A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter	N/A
Recruiting	`NCT05416086` - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study	N/A
Completed	`NCT03650556` - Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation	N/A
Recruiting	`NCT04085731` - Driver-guided Ablation of Persistent Atrial Fibrillatiom
Withdrawn	`NCT02344394` - Comparison of Hybrid Ablation and Pulmonary Vein Isolation Alone vs Hybrid Ablation With PVI Plus Catheter Ablation	N/A
Terminated	`NCT01683045` - Efficacy and Safety Study of the Estech COBRA® Surgical System to Treat Patients With a History of Irregular Heart Beats	N/A
Completed	`NCT01694563` - ABLATE Post Approval Study - Synergy Ablation Lesions for Non-Paroxysmal Atrial Fibrillation	N/A
Active, not recruiting	`NCT03643224` - DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation	N/A
Withdrawn	`NCT05093868` - Electrographic Flow Mapping Validation in Patients With Persistent Atrial Fibrillation (EVAL AF)	N/A
Completed	`NCT05152966` - Feasibility Study of the FARAPULSE™ Cardiac Ablation System Plus in the Treatment of Persistent Atrial Fibrillation(PersAFOne II)	N/A
Completed	`NCT05043883` - Automated Assessment of PVI Using a Novel EP Recording System	N/A
Completed	`NCT04022954` - HD Mapping of Atrial Fibrillation in Asia Pacific
Active, not recruiting	`NCT06124690` - Persistent Atrial Fibrillation Without the Evidence of Low-voltage Areas	N/A
Not yet recruiting	`NCT05454111` - CARTO-Finder Guided Ablation Versus Multiscale Entropy Guided Ablation in Persistent Atrial Fibrillation	N/A
Completed	`NCT06260670` - FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation	N/A
Active, not recruiting	`NCT05077670` - Hybrid Characterization of Driver Sites During Atrial Fibrillation and Sinus Rhythm
Withdrawn	`NCT03835338` - WATCHMAN for Concomitant Left Atrial Appendage Electrical Isolation and Occlusion to Treat Persistent Atrial Fibrillation Rhythm	N/A
Completed	`NCT02275104` - Multimodal Image Processing Software to Guide Cardiac Ablation Therapy	N/A
Not yet recruiting	`NCT05565183` - Combined Study of ATrial Strain and Voltage by High Density Mapping in Young Patients With Atrial Fibrillation.	N/A
Completed	`NCT02274857` - Randomized Evaluation of Atrial Fibrillation Treatment With Focal Impulse and Rotor Modulation Guided Procedures	N/A