Tailored Treatment of Permanent Atrial Fibrillation (TTOP-AF)
|Atrial Fibrillation||Procedure: Medtronic Cardiac Ablation System Drug: Class I or III Antiarrhythmic Medications||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Tailored Treatment of Permanent Atrial Fibrillation - TTOP-AF|
- Chronic Effectiveness [ Time Frame: 6 months ]
The chronic efficacy endpoint was a treatment success/failure measure for each subject computed at 6 months. Treatment success included:
- 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.
- The subject was off all antiarrhythmic drugs at 6 months (Ablation Management arm only)
- The Investigator judged all procedures to be acutely successful (Ablation Management arm only).
- Acute Safety [ Time Frame: 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 [ Time Frame: 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.
- Acute Efficacy [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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.
|Study Start Date:||May 2007|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Procedure: 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.
Active Comparator: 2
Drug: 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514735
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