Overview

Study of HD Mesh Ablation System for Treatment of Paroxysmal Atrial Fibrillation

Status:
Terminated
Trial end date:
2009-11-01
Target enrollment:
0
Participant gender:
All
Summary
This is a randomized controlled study of the Bard High Density Mesh Ablation System for treatment of paroxysmal atrial fibrillation. This study will determine if the HD Mesh Ablation System is as safe as and more effective than anti-arrhythmic drugs.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
C. R. Bard
Treatments:
Anti-Arrhythmia Agents
Criteria
Inclusion Criteria:

- Patients with symptomatic paroxysmal atrial fibrillation who have failed at least one
class I or III anti-arrhythmic drug

- Other inclusion criteria

Exclusion Criteria:

- Previous surgical or catheter ablation to treat AF

- Permanent AF

- Uncontrolled or unstable medical conditions

- Other exclusion criteria