The Maintenance of Human Atrial Fibrillation
Recruitment status was: Recruiting
Atrial fibrillation (AF) is the most prevalent heart rhythm disorder in the United States, affecting 2.5 million individuals in whom it may cause stroke, palpitations, heart failure, and even death. Unfortunately, therapy for AF is limited. Anti-arrhythmic or rate-controlling drugs are poorly tolerated, with frequent side effects and do not reduce stroke risk. Ablation is an emerging, minimally invasive therapy that has attracted considerable attention because it may eliminate AF. Unfortunately, AF ablation is technically challenging, with a success of only 50-70% (versus >90% for other arrhythmias) and serious risks. A major cause of these limitations is that the mechanisms for human AF are not known and thus ablation cannot be directed to them. As a result, AF ablation is empiric and results in extensive destruction of the atrium.
This project will perform research to better understand AF and determine if abnormal activity in small regions or more widespread regions of the heart cause AF. By performing these studies in patients during clinical procedures, this project may lead to a paradigm shift in the understanding and treatment of AF.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||The Maintenance of Human Atrial Fibrillation|
- recurrence of atrial fibrillation [ Time Frame: 1 year ] [ Designated as safety issue: No ]recurrence of AF measured using clinical follow-up with implanted devices in all patients who consent
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Patients with persistent, long standing persistent and paroxysmal AF, who will receive ablation at sites that potentially maintain human AF.
Patients with persistent, long standing persistent and paroxysmal AF, who receive conventional ablation as determined by the operator at each site, and based upon Heart Rhythm Society guidelines.
This proposal will test the hypothesis that spatially localized sites maintain ongoing human AF, so that ablation at these drivers may eliminate AF on long-term followup. The investigators will study atrial fibrillation in patients undergoing ablation, to identify regions that may be sustaining AF, then ablate at them.
The study design will be to identify sites that may be maintaining AF, using mapping of AF prior to ablation. Once identified, these sites will be targeted for ablated using traditional methods. This process will be repeated up to six times. The locations of these sites will be recorded, and compared to traditional sites for AF ablation, including the pulmonary veins and left atrial roof. They will also be studied for the presence of complex fractionated electrograms and high dominant frequency.
Patients with persistent, long standing persistent, and paroxysmal AF will be included, and patients will then be followed for 6-12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248156
|United States, California|
|University of California San Diego Medical Center|
|San Diego, California, United States, 92103|
|Veterans Affairs San Diego Medical Center|
|San Diego, California, United States, 92161|
|Principal Investigator:||Sanjiv Narayan, MD, PhD||University of California, San Diego|