Status:
COMPLETED
The Maintenance of Human Atrial Fibrillation
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Atrial Fibrillation
Arrhythmias, Cardiac
Eligibility:
All Genders
21+ years
Brief Summary
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. U...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA for STUDY SUBJECTS:
- patients undergoing electrophysiology study (EPS) for ablation of (a) paroxysmal AF (non-rheumatic) whose AF episodes self-terminate in \< 7 days, or (b) persistent AF (non-rheumatic) whose AF episodes last \>or= 7 days but terminate with DC cardioversion or anti-arrhythmic drugs and do not recur within 24 hours.
- AF patients must have failed \>or= 1 anti-arrhythmic drug
- INCLUSION CRITERIA for ALL SUBJECTS:
- will have a full evaluation focusing on diabetes mellitus, hypertension, coronary disease, left ventricular ejection fraction (LVEF). We will document whether AF relates to times of vagal activity (meals or sleep) or exercise. We will record the use of drugs affecting the renin-aldosterone-angiotensin system (RAAS) and statins, that may protect against atrial fibrosis and AF. We will document serum potassium level, since slight elevations slow CV in vitro. We will record 12-lead ECG and echocardiography for left atrial diameter, and stress test and/or coronary angiography if indicated.
- will have event monitor recordings with daily transmissions for at least one week to document AF burden (study subjects) or exclude AF (control subjects).
- must have with-held amiodarone for \> 30 days and other anti-arrhythmic drugs for \> 5 half-lives.
- EXCLUSION CRITERIA FOR ALL SUBJECTS:
- active coronary ischemia in the past year, since the protocol uses isoproterenol
- rheumatic valve disease, that leads to distinct AF and increases thromboembolic risk
- prior ablation or cardiac surgery, that alters atrial electrophysiology
- LA clot or dense contrast on TEE
- deranged serum electrolytes, and K+ outside 4.0-5.0 mmol/l
- left atrial diameter \> 60 mm
- LVEF \< 40% or New York Heart Association heart failure \> Class II, to exclude distinct, heart-failure related remodeling
- thrombotic disease, venous filters, transient ischemic attack or cerebrovascular accident, to minimize additional risk
- pregnancy, to minimize fluoroscopy. As part of routine clinical care, all female patients of childbearing age receive a ß-HCG pregnancy test. Any who test positive will not be included in the research study
- inability or unwillingness to provide informed consent
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01248156
Start Date
December 1 2010
End Date
June 1 2014
Last Update
August 15 2019
Active Locations (2)
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1
University of California San Diego Medical Center
San Diego, California, United States, 92103
2
Veterans Affairs San Diego Medical Center
San Diego, California, United States, 92161