Trials / Completed
CompletedNCT02255851
Sentinel(TM) Post-Market Registry
Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (actual)
- Sponsor
- Claret Medical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for TAVR. Subjects enrolled in the registry will undergo TAVR + Sentinel. Basic demographic information and detailed procedural data will be captured and documented in a registry case report form. All Sentinel filters will be sent for histopathology at an independent core-lab.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SENTINEL (Cerebral Protection System) |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2016-05-01
- Completion
- 2016-05-01
- First posted
- 2014-10-03
- Last updated
- 2018-05-23
Source: ClinicalTrials.gov record NCT02255851. Inclusion in this directory is not an endorsement.