Trials / Active Not Recruiting
Active Not RecruitingNCT05478304
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6,573 (actual)
- Sponsor
- AtriCure, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AtriClip LAA Exclusion System | LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery |
Timeline
- Start date
- 2023-01-25
- Primary completion
- 2031-12-01
- Completion
- 2032-04-01
- First posted
- 2022-07-28
- Last updated
- 2026-03-24
Locations
138 sites across 10 countries: United States, Australia, Austria, Belgium, Canada, Czechia, Germany, New Zealand, Spain, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05478304. Inclusion in this directory is not an endorsement.