Comparison of Two Pulmonary Vein Ablation Techniques for Persistent AF

Investigator Initiated Randomized Controlled Trial Comparing Two Radiofrequency Ablation Strategies in Patients With Persistent Atrial Fibrillation

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

Study Overview

• Status: Unknown
• Conditions: Persistent Atrial Fibrillation; Chronic Atrial Fibrillation
• Intervention / Treatment: Procedure: RF ablation PVI alone; Procedure: RF ablation PVI plus LPAW

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher E Woods, MD, PhD; Phone Number: 650-652-8600; Email: WoodC@sutterhealth.org
• Study Contact Backup: Name: Ann Campbell, RN, MBA; Phone Number: 650-367-5950; Email: ann.campbell@dignityhealth.org

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94062
      • Recruiting
      • Dignity Health, Sequoia Hospital
      • Contact: Ann Campbell, RN, MBA; Phone Number: 650-367-5950; Email: ann.campbell@dignityhealth.org
      • Contact: Christopher E Woods, MD, PhD; Phone Number: 650-652-8600; Email: woodsC@sutterhealth.org
      • Principal Investigator: Christopher E Woods, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RF ablation PVI alone; RF catheter ablation of pulmonary veins alone	Procedure: RF ablation PVI alone; A series of RF applications will be delivered around both sets of pulmonary veins with complete entry and exit block obtained around the antrums of all 4 pulmonary veins.; Other Names: Catheter ablation of the pulmonary veins
Experimental: RF ablation PVI plus LPAW; RF catheter ablation PVI plus left atrial posterior wall	Procedure: RF ablation PVI plus LPAW; A series of RF applications will be delivered around both sets of pulmonary veins with complete entry and exit block obtained around the antrums of all 4 pulmonary veins. In addition, a roof and posterior line will be placed in the left atrium to achieve entrance and exit block on the posterior wall. Entry block will be confirmed by placing a circular mapping catheter in multiple locations along the posterior wall and confirming lack of presence of any local potentials. Exit block will be confirmed on the posterior wall with pacing at 10 amps from the ablation catheter at multiple locations within the box as well as all lines.; Other Names: Catheter ablation of the pulmonary veins plus posterior wall

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year freedom from recurrent atrial arrhythmias	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.	1 Year

Collaborators and Investigators

• Sponsor: Sequoia Hospital
• Investigators: Principal Investigator: Christopher E Woods, MD, PhD, Dignity Health, Sequoia Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2017
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: September 24, 2017
• First Submitted That Met QC Criteria: September 24, 2017
• First Posted (Actual): September 27, 2017

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Catheter ablation; Persistent Atrial Fibrillation; Radiofrequency ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: Persistent AF Study 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No