Trials / Recruiting
RecruitingNCT06777368
REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 225 (estimated)
- Sponsor
- Medtronic Cardiovascular · Industry
- Sex
- All
- Age
- 18 Years – 105 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).
Detailed description
Primary Objectives: * To determine the acute and long-term outcomes of redo TAVR for the treatment of BVF affecting TAVs * To determine the factors which are associated with the acute and long-term outcomes of redo TAVR
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Medtronic TAV | Medtronic TAV where commercially available |
| DEVICE | Edwards TAV | Edwards TAV where commercially available. |
Timeline
- Start date
- 2025-02-06
- Primary completion
- 2029-03-01
- Completion
- 2033-07-01
- First posted
- 2025-01-15
- Last updated
- 2026-02-12
Locations
70 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06777368. Inclusion in this directory is not an endorsement.