Tailored Treatment of Permanent Atrial Fibrillation

NCT ID: NCT00514735

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2010-11-30

Brief Summary

The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac Ablation System compared to medical therapy in the persistent and long-standing persistent atrial fibrillation population.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Ablation Management

Group Type: EXPERIMENTAL

Medtronic Cardiac Ablation System

Intervention Type: PROCEDURE

Arm 1 (Ablation Management): Ablation procedures using investigational catheters in left atrium. Cardioversion could be used to restore sinus rhythm if needed.

2

Medical Management

Group Type: ACTIVE_COMPARATOR

Class I or III Antiarrhythmic Medications

Intervention Type: DRUG

Arm 2 (Medical Management): Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current cardioversions were also allowed at the discretion of the investigator.

Interventions

Medtronic Cardiac Ablation System

Arm 1 (Ablation Management): Ablation procedures using investigational catheters in left atrium. Cardioversion could be used to restore sinus rhythm if needed.

Intervention Type: PROCEDURE

Class I or III Antiarrhythmic Medications

Arm 2 (Medical Management): Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current cardioversions were also allowed at the discretion of the investigator.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• History of symptomatic, continuous atrial fibrillation defined as: Continuous atrial fibrillation lasting greater than 1 year but less than 4 years or nonself-terminating atrial fibrillation, lasting greater than 7 days but no more than 1 year, with at least one failed direct current cardioversion. A failed cardioversion was defined as an unsuccessful cardioversion or one in which normal sinus rhythm was established but not maintained beyond 7 days.
• Atrial fibrillation symptoms included the following: palpitations, fatigue,exertional dyspnea, exercise intolerance
• Age between 18 and 70 years
• Failure of at least one Class I or III rhythm control drug
• Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.

Exclusion Criteria

• Structural heart disease of clinical significance including:

• Previous cardiac surgery (excluding coronary artery bypass graft and mitral valve repair)
• Symptoms of congestive heart failure including, but not limited to, New York Heart Association (NYHA) Class III or IV congestive heart failure and/or documented ejection fraction <40% measured by acceptable cardiac testing
• Left atrial diameter >55 mm
• Moderate to severe mitral or aortic valvular heart disease
• Stable/unstable angina or ongoing myocardial ischemia
• Myocardial infarction (MI) within 3 months of enrollment
• Congenital heart disease (not including atrial septal defect or patent foramen ovale without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
• Prior atrial septal defect of patent foramen ovale closure with a device using a percutaneous approach
• Hypertrophic cardiomyopathy (left ventricular septal wall thickness >1.5 cm)
• Pulmonary hypertension (mean or systolic pulmonary artery pressure >50 mm Hg on Doppler echo)
• Any prior ablation for atrial fibrillation
• Enrollment in any other ongoing arrhythmia study
• Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study
• Active infection or sepsis
• Any history of cerebral vascular disease including stroke or transient ischemic attacks
• Pregnancy or lactation
• Left atrial thrombus at the time of ablation
• Untreatable allergy to contrast media
• Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
• History of blood clotting (bleeding or thrombotic) abnormalities
• Known sensitivities to heparin or warfarin
• Severe chronic obstructive pulmonary disease (defined as forced expiratory volume 1 (FEV1) <1)
• Severe co-morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Arizona Arrhythmia Research Center

Scottsdale, Arizona, United States

UCLA Cardiac Arrhythmia Center

Los Angeles, California, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Emory Crawford Long Hospital

Atlanta, Georgia, United States

Piedmont Hospital

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Krannert Institute of Cardiology

Indianapolis, Indiana, United States

Genesis Medical Center

Davenport, Iowa, United States

Iowa Heart Center

Des Moines, Iowa, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Washington Adventist Hospital

Takoma Park, Maryland, United States

Massachusetts General Hospital Cardiac Arrhythmia

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Lahey Clinic

Burlington, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Spectrum Health Research Department

Grand Rapids, Michigan, United States

University of Rochester

Rochester, New York, United States

Wake Forest University

Winston-Salem, North Carolina, United States

The Ohio State University

Columbus, Ohio, United States

Consultants in Cardiovascular Diseases

Erie, Pennsylvania, United States

Austin Heart

Austin, Texas, United States

Texas Heart Institute at St. Luke's Episcopal

Houston, Texas, United States

Sentara Cardiovascular Research Institute

Norfolk, Virginia, United States

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Countries

United States; Netherlands

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Related Links

http://www.ablationfrontiers.com

Company website

Other Identifiers

AFI-30

Identifier Type: -

Identifier Source: org_study_id