Comparison of Two Pulmonary Vein Ablation Techniques for Persistent AF
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03295422|
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : November 19, 2020
|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|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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.
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
|Contact: Christopher E Woods, MD, PhD||650-652-8600||WoodC@sutterhealth.org|
|Contact: Ann Campbell, RN, MBAfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Christopher E Woods, MD, PhD|
|Principal Investigator:||Christopher E Woods, MD, PhD||Dignity Health, Sequoia Hospital|