Comparison of Two Pulmonary Vein Ablation Techniques for Persistent AF
Primary Purpose
Chronic Atrial Fibrillation, Persistent Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RF ablation PVI alone
RF ablation PVI plus LPAW
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Atrial Fibrillation focused on measuring Persistent Atrial Fibrillation, Radiofrequency ablation, Catheter ablation
Eligibility Criteria
Inclusion Criteria:
- Have symptomatic persistent AF (i.e., a sustained episode lasting more than 7 days).
- Refractory to at least one antiarrhythmic agent.
- Undergoing ablation for the first time.
Exclusion Criteria:
- Paroxysmal AF
- Sustained atrial fibrillation lasting more than 3 years
- Left atrial diameter of 60 mm or greater
Sites / Locations
- Dignity Health, Sequoia HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
RF ablation PVI alone
RF ablation PVI plus LPAW
Arm Description
RF catheter ablation of pulmonary veins alone
RF catheter ablation PVI plus left atrial posterior wall
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03295422
Brief Title
Comparison of Two Pulmonary Vein Ablation Techniques for Persistent AF
Official Title
Investigator Initiated Randomized Controlled Trial Comparing Two Radiofrequency Ablation Strategies in Patients With Persistent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 25, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sequoia Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Atrial Fibrillation, Persistent Atrial Fibrillation
Keywords
Persistent Atrial Fibrillation, Radiofrequency ablation, Catheter ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RF ablation PVI alone
Arm Type
Active Comparator
Arm Description
RF catheter ablation of pulmonary veins alone
Arm Title
RF ablation PVI plus LPAW
Arm Type
Experimental
Arm Description
RF catheter ablation PVI plus left atrial posterior wall
Intervention Type
Procedure
Intervention Name(s)
RF ablation PVI alone
Other Intervention Name(s)
Catheter ablation of the pulmonary veins
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
RF ablation PVI plus LPAW
Other Intervention Name(s)
Catheter ablation of the pulmonary veins plus posterior wall
Intervention Description
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.
Primary Outcome Measure Information:
Title
1-year freedom from recurrent atrial arrhythmias
Description
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.
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have symptomatic persistent AF (i.e., a sustained episode lasting more than 7 days).
Refractory to at least one antiarrhythmic agent.
Undergoing ablation for the first time.
Exclusion Criteria:
Paroxysmal AF
Sustained atrial fibrillation lasting more than 3 years
Left atrial diameter of 60 mm or greater
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher E Woods, MD, PhD
Phone
650-652-8600
Email
WoodC@sutterhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ann Campbell, RN, MBA
Phone
650-367-5950
Email
ann.campbell@dignityhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher E Woods, MD, PhD
Organizational Affiliation
Dignity Health, Sequoia Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dignity Health, Sequoia Hospital
City
Redwood City
State/Province
California
ZIP/Postal Code
94062
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher E Woods, MD, PhD
Phone
650-652-8600
Email
woodsC@sutterhealth.org
First Name & Middle Initial & Last Name & Degree
Ann Campbell, RN, MBA
Phone
650-367-5950
Email
ann.campbell@dignityhealth.org
First Name & Middle Initial & Last Name & Degree
Christopher E Woods, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Two Pulmonary Vein Ablation Techniques for Persistent AF
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