Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: ADenosine Following Pulmonary Vein Isolation to Target Dormant Conduction Elimination: the ADVICE Trial
Brief Summary: Atrial fibrillation (AF) is the most common heart rhythm disorder, impairs quality of life and increases stroke risk and mortality. Despite advances in medical treatment, AF remains uncontrolled in many patients. In many patients, AF is initiated by abnormal electrical impulses from the pulmonary veins. A catheter ablation procedure called pulmonary vein isolation (PVI) has therefore been developed, using heat to isolate the PV foci from the heart. PVI is very effective, but must be repeated in up to 50% of cases because the foci isolation is not permanent after initial PVI. The intravenous administration of a drug called adenosine during the PVI procedure can unmask residual conduction that would otherwise remain unnoticed, so-called "dormant conduction". In our experience, additional ablation guided by adenosine reduces AF recurrence and the need for a repeat PVI procedure. However, the adenosine-guided approach has not yet been proven as standard therapy. The present study, to be conducted at 15 clinical centres in Canada, Europe and Australia is therefore intended to evaluate the efficacy of adenosine-guided ablation to prevent AF recurrence. Five hundred twenty-six patients will be included in the study, which should be completed within 2 years. In all patients, the presence of dormant conduction will be tested with adenosine during PVI. If dormant conduction is observed, additional ablation will be performed in half of these patients selected randomly. If there is no dormant conduction, randomly selected patients will be followed in a registry. If the adenosine-guided approach is demonstrated to improve the success rate of PVI procedures, it should become the standard approach for a "permanent cure" of AF, and therefore benefit patients by reducing arrhythmia recurrence, hospitalizations and the need for repeat interventions.


Options:
A: Arm Label: AAD:YES; Type: OTHER; Interventions: Drug: propafenone; flecainide; sotalol; dofetilide, Device: Radiofrequency catheter ablation | Arm Label: AAD:NO; Type: OTHER; Interventions: Device: Radiofrequency catheter ablation | Intervention Type: DRUG; Name: propafenone; flecainide; sotalol; dofetilide; Assigned to Arm(s): AAD:YES | Intervention Type: DEVICE; Name: Radiofrequency catheter ablation; Assigned to Arm(s): AAD:NO, AAD:YES
B: Arm Label: AAD therapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone), Procedure: ILR implantation | Arm Label: re-ablation procedure; Type: ACTIVE_COMPARATOR; Interventions: Procedure: re-ablation procedure, Procedure: ILR implantation | Intervention Type: DRUG; Name: Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone); Assigned to Arm(s): AAD therapy | Intervention Type: PROCEDURE; Name: re-ablation procedure; Assigned to Arm(s): re-ablation procedure | Intervention Type: PROCEDURE; Name: ILR implantation; Assigned to Arm(s): AAD therapy, re-ablation procedure
C: Arm Label: No Amiodarone; Type: ACTIVE_COMPARATOR; Interventions: Other: No Amiodarone | Arm Label: Amiodarone; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: No Amiodarone; Assigned to Arm(s): No Amiodarone
D: Arm Label: Dormant PV conduction; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Additional ablation until elimination of dormant conduction, Procedure: No additional ablation | Arm Label: No dormant PV conduction; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Registry group, Procedure: Usual medical care | Intervention Type: PROCEDURE; Name: Additional ablation until elimination of dormant conduction; Assigned to Arm(s): Dormant PV conduction | Intervention Type: PROCEDURE; Name: No additional ablation; Assigned to Arm(s): Dormant PV conduction | Intervention Type: PROCEDURE; Name: Registry group; Assigned to Arm(s): No dormant PV conduction | Intervention Type: PROCEDURE; Name: Usual medical care; Assigned to Arm(s): No dormant PV conduction

Answer: D