The Maintenance of Human Atrial Fibrillation

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of California, San Diego
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Sanjiv Narayan, MD, PhD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01248156
First received: November 24, 2010
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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.


Condition
Atrial Fibrillation
Arrhythmias, Cardiac

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Maintenance of Human Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 86
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)
Groups/Cohorts
Intervention
Patients with persistent, long standing persistent and paroxysmal AF, who will receive ablation at sites that potentially maintain human AF.
Control
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.

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 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects will be men and women of all races aged above 21 years undergoing clinically indicated ablation of persistent and paroxysmal AF subjects.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248156

Contacts
Contact: Sanjiv Narayan, MD, PhD (858) 552-8585 ext 2250 kcmills@ucsd.edu

Locations
United States, California
University of California San Diego Medical Center Recruiting
San Diego, California, United States, 92103
Contact: Sanjiv Narayan, MD, PhD    858-552-8585 ext 2250    kcmills@ucsd.edu   
Principal Investigator: Sanjiv Narayan, MD, PhD         
Veterans Affairs San Diego Medical Center Recruiting
San Diego, California, United States, 92161
Contact: Sanjiv Narayan, MD, PhD    858-552-8585 ext 2250    kcmills@ucsd.edu   
Principal Investigator: Sanjiv Narayan, MD, PhD         
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Sanjiv Narayan, MD, PhD University of California, San Diego
  More Information

No publications provided

Responsible Party: Sanjiv Narayan, MD, PhD, Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01248156     History of Changes
Other Study ID Numbers: 101311, K24HL103800
Study First Received: November 24, 2010
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014