Trials / Completed
CompletedNCT03287856
NVT ALLEGRA TAVI System TF in Failing Surgical Aortic Bioprosthesis
Investigation of the Safety and Performance of the NVT ALLEGRA TAVI System TF in Patients With Failed Surgical Aortic Bioprosthesis and Elevated Surgical Risk
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- NVT GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study investigates the technical feasibility of the replacement of failed surgical bioprosthetic aortic valves by the ALLEGRA Transcatheter Heart Valve (THV) and describes the safety and performance profile
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcatheter Aortic Valve Implantation (TAVI) | Implantation of the ALLEGRA Transcatheter Heart Valve in failing surgical bioprosthesis |
Timeline
- Start date
- 2017-08-11
- Primary completion
- 2018-09-27
- Completion
- 2019-10-27
- First posted
- 2017-09-19
- Last updated
- 2020-01-10
Locations
5 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT03287856. Inclusion in this directory is not an endorsement.