Trials / Completed
CompletedNCT00265629
RF Ablation of Atrial Fibrillation
A Clinical Investigation of Radiofrequency Ablation for the Treatment of Atrial Fibrillation Using the High Density Mesh Bard Ablation System
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- C. R. Bard · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
This is an early feasibility trial designed to demonstrate whether a new ablation device can be used safely and effectively in treating atrial fibrillation. This study is a prospective, nonrandomized, single-arm, multi-center trial to be conducted at a single study site
Detailed description
This study is intended to evaluate the safety and preliminary effectiveness of the RFMesh BAS for electrophysiological mapping and radiofrequency ablation in the region of the ostium of a targeted pulmonary vein in the treatment of drug refractory paroxysmal atrial fibrillation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RF catheter ablation | RF ablation using mesh device |
Timeline
- Start date
- 2005-08-01
- Primary completion
- 2009-09-01
- Completion
- 2009-10-01
- First posted
- 2005-12-15
- Last updated
- 2013-06-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00265629. Inclusion in this directory is not an endorsement.