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
Overview
- Phase
- Phase 4
- Intervention
- Antiarrhythmic drug
- Conditions
- Atrial Fibrillation
- Sponsor
- Valley Health System
- Locations
- 2
- Primary Endpoint
- Percentage of AF burden
- Status
- Withdrawn
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
Jonathan Steinberg,MD
Director Arrhythmia Services, Valley Health System
Valley Health System
Eligibility Criteria
Inclusion Criteria
- •Patients with recently diagnosed paroxysmal AF who are eligible to receive specific rhythm control therapy
Exclusion Criteria
- •Previous treatment with Class IC or class III AAD
- •Previous AF ablation procedure
- •Congestive heart failure (NYHA III-IV functional class)
- •Left Ventricle ejection fraction less than 35%
- •Left atrial diameter \> 55mm
- •Unwillingness to participate
Arms & Interventions
Antiarrhythmic drug
Class I or III antiarrhythmic drug
Intervention: Antiarrhythmic drug
Catheter ablation
Pulmonary vein isolation
Intervention: Catheter ablation
Outcomes
Primary Outcomes
Percentage of AF burden
Time Frame: 4 months
The percentage of AF burden defined through continuous monitoring using an implnatage loop recorder (ILR)
Secondary Outcomes
- All-death death(4 months)