NCT01505296

Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation

Randomized Comparison of Catheter Ablation Versus Anti-arrhythmic Drug Therapy in Patients With Recently Diagnosed Paroxysmal Atrial Fibrillation as Assessed by a Continuous Implantable Monitor

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Valley Health System · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The objective is to compare the progression of Atrial Fib (AF) burden by continuous monitoring in patients with recently diagnosed paroxysmal AF treated by catheter ablation (PVI) versus anti-arrhythmic drug (AAD) therapy.

Detailed description

Randomized, multicenter clinical trial comparing medical therapy (Group I) with ablation therapy(Group II). Randomization will be determined by opening a sealed envelope. All patients will be implanted with an implantable loop recorder and followed every three months.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Antiarrhythmic drug	propafenone, flecainide, sotalol, dofetilide
PROCEDURE	Catheter ablation	Complete PVI

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-01-06
• Last updated: 2014-12-16

Locations

2 sites across 2 countries: United States, Russia