Trials / Completed
CompletedNCT02105584
Prospective, Non-randomized, Safety and Efficacy Study of a New Occluder Design for Minimally Invasive Closure of the Left Atrial Appendage (LAA) in Patients With Atrial Fibrillation
Prospective, Non-randomized, Safety and Efficacy Study of a New Occluder Design for Minimally Invasive Closure of the Left Atrial Appendage in Patients With Atrial Fibrillation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 78 (actual)
- Sponsor
- Occlutech International AB · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, non-randomized, study of the safety and efficacy of the Occlutech® LAA occluder indicated for percutaneous LAA closure in adult male or female patients with atrial fibrillation. Safety and efficacy will be assessed at day 1, 30 and 90, and after 1 year following implantation of an Occlutech® LAA Occluder.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Implantation of LAA closure device |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2017-09-01
- Completion
- 2017-09-01
- First posted
- 2014-04-07
- Last updated
- 2018-04-05
Locations
7 sites across 2 countries: Germany, United Kingdom
Source: ClinicalTrials.gov record NCT02105584. Inclusion in this directory is not an endorsement.