Trials / Not Yet Recruiting
Not Yet RecruitingNCT06400342
Randomized Evaluation for Failed TAVR
Randomized Evaluation of Valve-In-Valve Versus Explantation for Failed TAVR (REVIVE-TAVR)
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 264 (estimated)
- Sponsor
- Medstar Health Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
REVIVE TAVR is an acronym for the Randomized Evaluation of Valve-In-Valve versus Explantation for failed TAVR. This is a prospective, multicenter, global randomized trial investigating the safety and efficacy of reintervention for transcatheter heart valve (THV) failure by comparing redo-TAVR (TAV-in-TAV) with TAVR surgical explantation (TAVR-explant) in subjects who are suitable for both options in a real-world clinical setting
Conditions
- Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure
- Prosthetic Valve Malfunction
- Prosthesis Failure
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | TAVR-explant | Surgical explantation of failed THV followed by surgical aortic valve replacement and any other cardiac surgeries deemed necessary. |
| DEVICE | Redo-TAVR | Repeat transcatheter aortic valve implantation within a failed THV. |
Timeline
- Start date
- 2025-03-01
- Primary completion
- 2034-05-01
- Completion
- 2036-05-01
- First posted
- 2024-05-06
- Last updated
- 2025-01-24
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06400342. Inclusion in this directory is not an endorsement.