Trials / Active Not Recruiting
Active Not RecruitingNCT06580275
The GLACE Study: Evaluating CLAAS With ICE Guided LAA Closure
The GLACE Study: A Prospective Multi-center Single Arm Study Evaluating the Safety and Performance of the CLAAS Device With ICE Guided LAA Closure.
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Conformal Medical, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The CLAAS® device will be evaluated for safety and performance in the reduction of stroke in subjects with non-valvular atrial fibrillation under intracardiac echocardiography (ICE) imaging for left atrial appendage closure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CLAAS | All eligible subjects will have an LAA closure attempt using the CLAAS device guided by ICE technology. |
Timeline
- Start date
- 2024-09-24
- Primary completion
- 2025-11-10
- Completion
- 2026-09-22
- First posted
- 2024-08-30
- Last updated
- 2026-02-25
Locations
4 sites across 3 countries: Czechia, Denmark, Italy
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06580275. Inclusion in this directory is not an endorsement.