Trials / Completed
CompletedNCT04618718
The PROTEMBO C Trial
Cerebral Protection in Transcatheter Aortic Valve Replacement - The PROTEMBO C Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- Protembis GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The PROTEMBO C Trial is an international, multi-center, single arm, non-inferiority study of the safety and performance of using the ProtEmbo System for cerebral embolic protection in subjects with severe native aortic valve stenosis indicated for TAVR.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | cerebral embolic protection during TAVR | The ProtEmbo system is an adjunctive device placed in the central arterial system at the beginning of a TAVR procedure to deflect embolic particles during the procedure and removed following the completion of the procedure. |
Timeline
- Start date
- 2020-07-31
- Primary completion
- 2022-11-23
- Completion
- 2022-11-23
- First posted
- 2020-11-06
- Last updated
- 2025-05-08
- Results posted
- 2025-05-08
Locations
8 sites across 3 countries: Germany, Latvia, Poland
Source: ClinicalTrials.gov record NCT04618718. Inclusion in this directory is not an endorsement.