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Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atrial Fibrillation; Arrhythmia

Intervention: Rate Control (Drug); Ablation Therapy (Device); Rate Control (Drug); Rate control (Drug); Rate control (Drug); Rate control (Drug); Rate Control (Drug); Rate Control (Drug); Rate Control (Drug); Rhythm Control (Drug); Rhythm control (Drug); Rhythm control (Drug); Rhythm control (Drug); Rhythm control (Drug); Rhythm control (Drug)

Phase: N/A

Status: Completed

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Douglas L. Packer, M.D., Principal Investigator, Affiliation: Mayo Clinic

Summary

The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.

Clinical Details

Official title: Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation - Pilot Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up

Detailed description: The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs.

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Have documented AF, which warrants active drug or ablative treatment

- Be eligible for both catheter ablation and at least 2 sequential anti-arrhythmic

drugs and/or 3 sequential rate control drugs

- Be >65 yrs of age, or <65 yrs with one or more of the following risk factors for

stroke: Hypertension, Diabetes, Congestive heart failure (including systolic or diastolic heart failure), Prior stroke or transient ischemic attack, Left atrium >4. 5 cm, ejection fraction <35% by echocardiogram, radionuclide evaluation or contrast ventriculography Exclusion Criteria:

- Previously failed 2 or more membrane active anti-arrhythmic drugs

- Efficacy failure of a full dose Amiodarone trial of >12 weeks duration

- Any amiodarone therapy in the past three months

- Reversible causes of AF including thyroid disorders, acute alcohol intoxication,

recent major surgical procedures, or trauma

- Lone atrial fibrillation in the absence of risk factors for stroke in patients <65

years of age

- Recent cardiac events including myocardial infarction, percutaneous intervention, or

valve or coronary bypass surgery in the preceding 3 months

- Hypertrophic obstructive cardiomyopathy

- Class IV angina or congestive heart failure

- Planned heart transplantation

- Other mandated anti-arrhythmic drug therapy

- Heritable arrhythmias or increased risk for "torsade de pointes" (a specific, rare

variety of ventricular tachycardia) with class I or III drugs

- Prior left atrial catheter ablation with the intention to treat AF

- Patients with other arrhythmias requiring ablative therapy

- Prior surgical interventions for AF such as the MAZE procedure

- Prior atrioventricular nodal ablation

- Medical conditions limiting expected survival to <1 year

- Contraindication to warfarin anti-coagulation

- Women of childbearing potential

- Participation in any other clinical mortality trial

- Unable to give informed consent

Locations and Contacts

Universtity of Alabama Hospital, Birminham, Alabama 35233, United States

Good Samaritan Hospital, Los Angeles, California 90017, United States

Loyola University, Maywood, Illinois 60626, United States

Mercy Medical Center, Des Moines, Iowa 50314, United States

Johns Hopkins Hospital, Baltimore, Maryland 21287, United States

Brigham and Womens Hospital, Boston, Massachusetts 02115, United States

Mayo Clinic, Rochester, Minnesota 55902, United States

Ohio State University Medical Center, Columbus, Ohio 43210, United States

University of Pennsylvania Health, Philadelphia, Pennsylvania 19104, United States

Intermountain Medical Center, Murray, Utah 84157, United States

Additional Information

Mayo Clinic Clinical Trials

Related publications:

Cleland JG, Coletta AP, Buga L, Ahmed D, Clark AL. Clinical trials update from the American College of Cardiology meeting 2010: DOSE, ASPIRE, CONNECT, STICH, STOP-AF, CABANA, RACE II, EVEREST II, ACCORD, and NAVIGATOR. Eur J Heart Fail. 2010 Jun;12(6):623-9. doi: 10.1093/eurjhf/hfq083.

Starting date: September 2006
Last updated: December 3, 2012

Page last updated: August 23, 2015

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