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First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment: A Multi-center Randomized Trial (RAAFT)
The purpose of this study is to determine whether catheter-based pulmonary vein isolation is superior to antiarrhythmic drugs as first line therapy in patients with symptomatic paroxysmal recurrent atrial fibrillation not previously treated with therapeutic doses of antiarrhythmic drugs.
Details
| Lead sponsor | Population Health Research Institute |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 127 |
| Start date | 2006-08 |
| Completion | 2012-02 |
Conditions
- Atrial Fibrillation
Interventions
- Pulmonary Vein Isolation performed by Catheter Ablation
- Conventional Antiarrhythmic Drug Therapy
Primary outcomes
- Number of Participants With Recurrence of Atrial Tachyarrhythmia — Assessed during 21 month follow-up period
Recurrence of electrocardiographically documented atrial fibrillation, atrial flutter or atrial tachycardia lasting \>30 seconds during Follow-up Period. The follow-up period begins 90 days after randomization (the blanking period during which antiarrhythmic drugs are titrated or catheter ablation is performed). - Comparison of Proportion of Patients With an Occurrence of Any of a Cluster of Serious Complications in Either Arm — Assessed during entire 24 month study period
Ablation arm cluster: death, cardiac tamponade, severe PV stenosis\>70%, atrioesophageal fistula, thromboembolism, vascular complications (i.e. arterial pseudoaneurysm, arteriovenous fistula and hematoma leading to transfusion), phrenic nerve injury or complete AV block requiring permanent pacemaker implantation. Antiarrhythmic drug arm cluster: Death, torsade de pointes, bradycardia leading to pacemaker insertion, syncope, QRS duration prolongation \> 50% of baseline, 1:1 atrial flutter or any other significant adverse events that leads to drug discontinuation.
Countries
United States, Canada, Czechia, Germany, Italy