Last reviewed · How we verify
Atrial Fibrillation Ablation The Hybrid Approach Versus Traditional Management (AF)
Rationale: To determine the most beneficial ablation methodology for individual patients with paroxysmal or persistent atrial fibrillation (defined by the Heart Rhythm Society) as surgeons and electrophysiologists work together on a convergent procedure (hybrid) to place the epicardial and endocardial ablation lines. Objectives: Catheter and surgical ablation are being offered today to patients with drug refractory and symptomatic atrial fibrillation. This study is designed to assess the most efficient ablation approach in patients with paroxysmal and persistent atrial fibrillation. In patients with left atrium size of less than 5.0 cm, a Hybrid approach (pulmonary vein isolation performed surgically will be combined with right and left atrial flutter lines performed using a transcatheter approach) will be compared to percutaneous catheter ablation to isolate the pulmonary veins and apply the left and right atrial flutter lines with removal of LA appendage. In the group of patients with left atrial size 5.0-6.0 cm the Hybrid approach is going to be compared to the minimally invasive Cox-Maze III procedure. Our hypotheses with regard to the rate of return to sinus rhythm off antiarrhythmic drugs at 6 months will demonstrate that the Hybrid approach is going to be a: superior to percutaneous catheter ablation in the less than 5 cm left atrial group and b: non-inferior when compared to the Cox-Maze III procedure in the 5-6 cm left atrial cm group. We hypothesize that the safety of all procedures will show no differences and that there will be no differences in clinical complications between groups.
Details
| Lead sponsor | Inova Health Care Services |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | WITHDRAWN |
| Start date | 2011-05 |
| Completion | 2014-09 |
Conditions
- Ablation of Atrial Fibrillation
Interventions
- Pulmonary vein isolation ablation procedure for atrial fibrillation
- Hybrid procedure for ablation of atrial fibrillation
- The Cox Maze Procedure for Ablation of Atrial Fibrillation
- Hybrid Procedure for Left Atrium >5 cm but < 6.1 cm
Primary outcomes
- Return to sinus rhythm rate — 2-3 years
The primary outcome will be the rate of return to sinus rhythm as defined by the Heart Rhythm Society Guidelines (sinus rhythm maintained off anti arrhythmic medications and any monitored atrial arrhythmia greater than 30 seconds will be considered a recurrence) at 6 months.