Trials / Completed
CompletedNCT01196897
Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients (EVOLVE)
Evaluation of the Next Generation WATCHMAN LAA Closure Technology in Non-Valvular AF Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 69 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the next generation WATCHMAN Left Atrial Appendage (LAA) Closure Device as implanted in patients with non-valvular atrial fibrillation (AF) with a CHADS2 stroke risk stratification score of 1 or greater. This is a prospective, non-randomized study to evaluate the initial use of the next generation WATCHMAN Device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | WATCHMAN LAA Closure Technology (Gen 4.0) | Implantation of the WATCHMAN device into the left atrial appendage. |
Timeline
- Start date
- 2009-05-01
- Primary completion
- 2012-09-01
- Completion
- 2013-11-01
- First posted
- 2010-09-09
- Last updated
- 2015-12-08
Locations
3 sites across 2 countries: Czechia, Germany
Source: ClinicalTrials.gov record NCT01196897. Inclusion in this directory is not an endorsement.