Trials / Completed
CompletedNCT00318565
Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter
Navistar Thermocool Evaluation of the Catheter With the Stockert 70 Radiofrequency Generator for Endocardial Ablation in Patients With Typical Atrial Flutter
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 291 (actual)
- Sponsor
- Biosense Webster, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to provide additional corroborative safety and efficacy data for the Navistar Thermocool catheter for the treatment of subjects with typical atrial flutter (AFL).
Detailed description
This study is a prospective, non-randomized, single-arm, multi-center condition of approval evaluation. The device is currently FDA approved for commercial distribution. Subjects with symptomatic typical atrial flutter will be considered for the condition of approval study. This study will be conducted at up to 30 centers in a minimum of 221 evaluable subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | RF energy delivery for treatment of Typical Atrial flutter | Navistar ThermoCool catheter |
Timeline
- Start date
- 2006-01-01
- Primary completion
- 2007-09-01
- Completion
- 2008-02-01
- First posted
- 2006-04-27
- Last updated
- 2012-03-05
- Results posted
- 2010-03-02
Locations
23 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00318565. Inclusion in this directory is not an endorsement.