Trials / Completed
CompletedNCT03325283
The PROTEMBO SF Trial
Cerebral Protection in Transcatheter Aortic Valve Replacement
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Protembis GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The PROTEMBO SF Trial is a prospective, observational, multi-center, intention-to-treat study of the safety and feasibility of the ProtEmbo Cerebral Protection System in subjects with severe symptomatic native aortic valve stenosis indicated for TAVR.
Detailed description
The PROTEMBO SF Trial is a prospective, single arm, observational, multi-center, intention-to-treat study of the safety and feasibility of the ProtEmbo Cerebral Protection System in subjects with severe symptomatic native aortic valve stenosis indicated for TAVR.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ProtEmbo Cerebral Protection System | A catheter-based embolic deflection device will be positioned in the arch of the aorta to prevent debris liberated during the TAVR procedure from entering the three major vessels of the aortic arch. |
Timeline
- Start date
- 2017-08-09
- Primary completion
- 2018-08-31
- Completion
- 2018-10-30
- First posted
- 2017-10-30
- Last updated
- 2018-10-31
Locations
2 sites across 2 countries: Ireland, Latvia
Source: ClinicalTrials.gov record NCT03325283. Inclusion in this directory is not an endorsement.