Comparison of Two Pulmonary Vein Ablation Techniques for Persistent AF
| Status: | Recruiting |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/29/2017 |
| Start Date: | August 25, 2017 |
| End Date: | December 31, 2019 |
| Contact: | Christopher E Woods, MD, PhD |
| Email: | WoodC@sutterhealth.org |
| Phone: | 650-652-8600 |
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
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
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 100 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.
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 100 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.
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
We found this trial at
1
site
170 Alameda de las Pulgas
Redwood City, California 94062
Redwood City, California 94062
Principal Investigator: Christopher E Woods, MD, PhD
Phone: 650-652-8600
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