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Comparison of Two Pulmonary Vein Ablation Techniques for Persistent AF

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ClinicalTrials.gov Identifier: NCT03295422
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Christopher E. Woods, MD, PhD, Sequoia Hospital

Study Description
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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

Condition or disease Intervention/treatment Phase
Chronic Atrial Fibrillation Persistent Atrial Fibrillation Procedure: RF ablation PVI alone Procedure: RF ablation PVI plus LPAW Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigator Initiated Randomized Controlled Trial Comparing Two Radiofrequency Ablation Strategies in Patients With Persistent Atrial Fibrillation
Actual Study Start Date : August 25, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Catheter ablation of the pulmonary veins plus posterior wall


Outcome Measures
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Primary Outcome Measures :
  1. 1-year freedom from recurrent atrial arrhythmias [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295422


Contacts
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Contact: Christopher E Woods, MD, PhD 650-652-8600 WoodC@sutterhealth.org
Contact: Ann Campbell, RN, MBA 650-367-5950 ann.campbell@dignityhealth.org

Locations
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United States, California
Dignity Health, Sequoia Hospital Recruiting
Redwood City, California, United States, 94062
Contact: Christopher E Woods, MD, PhD    650-652-8600    woodsC@sutterhealth.org   
Contact: Ann Campbell, RN, MBA    650-367-5950    ann.campbell@dignityhealth.org   
Principal Investigator: Christopher E Woods, MD, PhD         
Sponsors and Collaborators
Sequoia Hospital
Investigators
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Principal Investigator: Christopher E Woods, MD, PhD Dignity Health, Sequoia Hospital
  Study Documents (Full-Text)

Documents provided by Christopher E. Woods, MD, PhD, Sequoia Hospital:
Study Protocol  [PDF] August 8, 2019

More Information
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Responsible Party: Christopher E. Woods, MD, PhD, Study Principal Investigator, Sequoia Hospital
ClinicalTrials.gov Identifier: NCT03295422    
Other Study ID Numbers: Persistent AF Study 01
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christopher E. Woods, MD, PhD, Sequoia Hospital:
Persistent Atrial Fibrillation
Radiofrequency ablation
Catheter ablation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes