Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Conventional Antiarrhythmic Drug Therapy · 1 trial · 1 indication
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 ...
Conventional Antiarrhythmic Drug Therapy is used for the treatment of Atrial Fibrillation. It is a small molecule therapy being developed by Johnson & Johnson. The therapy is currently in Phase 3 clinical development as an investigational treatment for this condition.
Conventional Antiarrhythmic Drug Therapy is being developed by Johnson & Johnson, which is listed on the stock exchange under the ticker JNJ. The therapy is a small molecule intended for the treatment of Atrial Fibrillation and is currently in Phase 3 clinical development.
Conventional Antiarrhythmic Drug Therapy is in Phase 3 clinical development. It is an investigational therapy for Atrial Fibrillation and has not been approved by regulatory authorities. The therapy is being studied in a completed Phase 3 clinical trial.
Conventional Antiarrhythmic Drug Therapy has one completed clinical trial, identified as NCT00392054. This Phase 3 trial, titled 'First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment (The RAAFT Study)', enrolled 127 participants with Atrial Fibrillation across the United States, Canada, Czechia, Germany, and Italy.
Yes, Conventional Antiarrhythmic Drug Therapy refers to the antiarrhythmic drug arm in the RAAFT study (NCT00392054). This Phase 3 trial compared first-line radiofrequency ablation with antiarrhythmic drugs for the treatment of Atrial Fibrillation, and the therapy is being developed by Johnson & Johnson.