Trials / Completed
CompletedNCT04149535
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3,000 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sentinel® Cerebral Protection System | cerebral embolic protection system |
Timeline
- Start date
- 2020-02-07
- Primary completion
- 2022-02-01
- Completion
- 2022-02-01
- First posted
- 2019-11-04
- Last updated
- 2023-02-02
- Results posted
- 2023-02-02
Locations
57 sites across 6 countries: United States, Australia, Denmark, France, Germany, Italy
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04149535. Inclusion in this directory is not an endorsement.