Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00392054 | First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment (The RAAFT Study) | PHASE3 | COMPLETED | 127 | — | — | Aug 1, 2006 | Feb 1, 2012 | Jan 31, 2020 | 16 | United States, Canada +3 |
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).
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.
| Arm | Type | Description |
|---|---|---|
| Catheter Ablation | EXPERIMENTAL | Pulmonary vein isolation performed by catheter ablation for the prevention of recurrence of symptomatic atrial fibrillation |
| Antiarrhythmic Drug Therapy | ACTIVE_COMPARATOR | Conventional antiarrythmic drug therapy for the prevention of recurrence of symptomatic atrial fibrillation |
| Name | Type | Description |
|---|---|---|
| Pulmonary Vein Isolation performed by Catheter Ablation | PROCEDURE | Ablation will be done to achieve entrance block into all pulmonary veins. |
| Conventional Antiarrhythmic Drug Therapy | DRUG | Anti-Arrhythmic Drugs per ACC/AHA 2006 Guidelines for the Management of Patients with AF |
Inclusion Criteria: 1. Age \> 18 and ≤ 75 years old. 2. Symptomatic, recurrent paroxysmal AF lasting \> 30 seconds (at least 4 episodes within the prior 6 months). At least one episode must be documented by Holter,12-lead ECG, event monitor or rhythm strip. Exclusion Criteria: 1. Documented LVEF ...