Tailored Treatment of Permanent Atrial Fibrillation
- Conditions
- Atrial Fibrillation
- Interventions
- Procedure: Medtronic Cardiac Ablation SystemDrug: Class I or III Antiarrhythmic Medications
- Registration Number
- NCT00514735
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Medtronic Cardiac Ablation System Ablation Management 2 Class I or III Antiarrhythmic Medications Medical Management
- Primary Outcome Measures
Name Time Method Chronic Effectiveness 6 months 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).Acute Safety 7 days 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.
Chronic Safety 6 months 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.
- Secondary Outcome Measures
Name Time Method Acute Efficacy Procedure conclusion A treatment success/failure up to the conclusion of the procedure for each subject in Ablation Management. A subject was considered successfully treated if the following were true:
* Medtronic ablation catheters were used to achieve procedure success.
* All accessible pulmonary veins were isolated.
* At least 50% reduction of complex fractionated atrial electrograms mapped and ablated with Medtronic ablation catheters.
* Sinus rhythm was achieved upon leaving the electrophysiology lab (±cardioversion).Improvement of Left Atrial Size at 6 Months Compared to Baseline. 6 months Left atrial diameter (LAD), as measured by transthoracic echocardiogram (TTE) looking at the longitudinal long axis at baseline and at the 6 month follow-up visit in both the Ablation and Medical Management arms.
Improvement of Left Ventricular Ejection Fraction at 6 Months Compared to Baseline. 6 months Left ventricular ejection fraction (LVEF), as measured by transthoracic echocardiogram at baseline and 6 months in both the Ablation and Medical Management arms.
Improvement in Atrial Fibrillation (AF) Symptom Severity Scores Over 6 Months Compared to Baseline. 6 months The severity of subject's atrial fibrillation related symptoms on a scale from 1 (no symptoms) to 5 (most severe). The symptoms included palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and lack of energy during exertion or exercise. The scores were tabulated at the 1, 3 and 6 month follow-up visits. Scores could range from 5 to 25, indicating a spectrum of subject status from asymptomatic to severely symptomatic.
Improved Quality of Life Over 6 Months Compared to Baseline. 6 months The SF-36 questionnaire was administered to subjects at baseline, 1, 3 and 6 month visits. The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based Physical Component Score and Mental Component Score. The possible range for Physical Component Score and Mental Component Score is 0 to 100. The higher score, the better quality of life.
Trial Locations
- Locations (24)
UCLA Cardiac Arrhythmia Center
🇺🇸Los Angeles, California, United States
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
Texas Heart Institute at St. Luke's Episcopal
🇺🇸Houston, Texas, United States
Emory Crawford Long Hospital
🇺🇸Atlanta, Georgia, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Krannert Institute of Cardiology
🇺🇸Indianapolis, Indiana, United States
Iowa Heart Center
🇺🇸Des Moines, Iowa, United States
Genesis Medical Center
🇺🇸Davenport, 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
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Spectrum Health Research Department
🇺🇸Grand Rapids, Michigan, United States
Consultants in Cardiovascular Diseases
🇺🇸Erie, Pennsylvania, United States
Austin Heart
🇺🇸Austin, Texas, United States
Sentara Cardiovascular Research Institute
🇺🇸Norfolk, Virginia, United States
St. Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
University of Rochester
🇺🇸Rochester, New York, United States
Arizona Arrhythmia Research Center
🇺🇸Scottsdale, Arizona, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States