An observational study in Atrial Fibrillation and Arrhythmias, Cardiac, sponsored by University of California, San Diego. Completed at 2 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2019-08-15.
Sponsored by University of California, San Diego · Observational
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.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 5 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects will be men and women of all races aged above 21 years undergoing clinically indicated ablation of persistent and paroxysmal AF subjects.
INCLUSION CRITERIA for STUDY SUBJECTS:
INCLUSION CRITERIA for ALL SUBJECTS:
EXCLUSION CRITERIA FOR ALL SUBJECTS:
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.
recurrence of atrial fibrillation
recurrence of AF measured using clinical follow-up with implanted devices in all patients who consent
Time frame: 1 year
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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University of California, San Diego