Tailored Treatment of Permanent Atrial Fibrillation

NCT00514735 | Completed Phase 3 Results DMC

• 1 other identifier: AFI-30
• Study Type: interventional
• Target: 210
• Locations: 2 countries
• Sites: 24

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

Keywords

atrial fibrillation

Outcome Measures

Primary Outcomes (3)

• Chronic Effectiveness

  The chronic efficacy endpoint was a treatment success/failure measure for each subject computed at 6 months. Treatment success included: 1. A 90% reduction in clinically significant atrial fibrillation from baseline to the 6 month time point based on a Holter recording. Clinically significant atrial fibrillation was defined as sustained atrial fibrillation lasting more than 10 minutes. 2. The subject was off all antiarrhythmic drugs at 6 months (Ablation Management arm only) 3. The Investigator judged all procedures to be acutely successful (Ablation Management arm only).

  6 months

• Acute Safety

  The primary endpoint for acute safety was a success/failure variable calculated for each subject in Ablation Management at the 7 day post-procedure time point. Any subject with at least one adverse event adjudicated by the Data Safety Monitoring Board as both serious and either probably or definitely procedure and/or device-related occurring within 7 days of the ablation procedure was considered an acute safety failure, regardless of whether the event occurred following the index or retreatment ablation procedure.

  7 days

• Chronic Safety

  The primary endpoint for chronic safety was a success/failure variable calculated for each subject at 6 months. Any subject that had at least one adverse event that met designated seriousness and relatedness criteria for the particular treatment group as adjudicated by the Data Safety Monitoring Board was considered a chronic safety failure. Adverse events in Ablation Management that were acute (≤7 days) were not included in the chronic safety primary endpoint. Given the disparity in the length of time at risk between treatment arms,the Chronic Safety endpoint was not statistically powered.

  6 months

Secondary Outcomes (5)

• Acute Efficacy

  Procedure conclusion

• Improvement of Left Atrial Size at 6 Months Compared to Baseline.

  6 months

• Improvement of Left Ventricular Ejection Fraction at 6 Months Compared to Baseline.

  6 months

• Improvement in Atrial Fibrillation (AF) Symptom Severity Scores Over 6 Months Compared to Baseline.

  6 months

• Improved Quality of Life Over 6 Months Compared to Baseline.

  6 months

Study Arms (2)

1

EXPERIMENTAL

Ablation Management

Procedure: Medtronic Cardiac Ablation System

2

ACTIVE COMPARATOR

Medical Management

Drug: Class I or III Antiarrhythmic Medications

Interventions

Medtronic Cardiac Ablation System PROCEDURE

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

1

Class I or III Antiarrhythmic Medications 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.

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (24)

Arizona Arrhythmia Research Center

Scottsdale, Arizona, 85251, United States

Location

UCLA Cardiac Arrhythmia Center

Los Angeles, California, 90095, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Emory Crawford Long Hospital

Atlanta, Georgia, 30308, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Krannert Institute of Cardiology

Indianapolis, Indiana, 46202, United States

Location

Genesis Medical Center

Davenport, Iowa, 52803, United States

Location

Iowa Heart Center

Des Moines, Iowa, 50309, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20912, United States

Location

Massachusetts General Hospital Cardiac Arrhythmia

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Spectrum Health Research Department

Grand Rapids, Michigan, 49503, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Consultants in Cardiovascular Diseases

Erie, Pennsylvania, 16502, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

Texas Heart Institute at St. Luke's Episcopal

Houston, Texas, 77030, United States

Location

Sentara Cardiovascular Research Institute

Norfolk, Virginia, 23507, United States

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Related Publications (34)

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Related Links

• Company website

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

\- The study population was mostly Caucasian men.

Results Point of Contact

• Title: Linda Nelson, Director of Clinical Research
• Organization: Medtronic

linda.k.nelson@medtronic.com

763-526-2891

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 10, 2007
• Study Start: May 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: October 16, 2018
• Results First Posted: May 9, 2012

Record last verified: 2018-09

Locations

US (23); NL (1)