Comparison of Two Pulmonary Vein Ablation Techniques for Persistent AF

Not Applicable

• Conditions: Chronic Atrial Fibrillation; Persistent Atrial Fibrillation
• Interventions: Procedure: RF ablation PVI plus LPAW; Procedure: RF ablation PVI alone

• Registration Number: NCT03295422
• Lead Sponsor: Sequoia Hospital

Brief 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

Detailed 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 Timeline

• Study Start: 2017-08-25
• Study First Submitted: 2017-09-24
• Study First Submitted QC: 2017-09-24
• Study First Posted: 2017-09-27
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-19
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Have symptomatic persistent AF (i.e., a sustained episode lasting more than 7 days).
2. Refractory to at least one antiarrhythmic agent.
3. Undergoing ablation for the first time.

Exclusion Criteria

1. Paroxysmal AF
2. Sustained atrial fibrillation lasting more than 3 years
3. Left atrial diameter of 60 mm or greater

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RF ablation PVI plus LPAW	RF ablation PVI plus LPAW	RF catheter ablation PVI plus left atrial posterior wall
RF ablation PVI alone	RF ablation PVI alone	RF catheter ablation of pulmonary veins alone

Primary Outcome Measures

Name	Time	Method
1-year freedom from recurrent atrial arrhythmias	1 Year	The primary hypotheses that PVI+PI will lead to a greater percentage of patients free from atrial arrhythmias after single ablation procedures than PVI alone.

Trial Locations

Locations (1)

Dignity Health, Sequoia Hospital; 🇺🇸 Redwood City, California, United States