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NOT YET RECRUITING
NCT06400342
NA

Randomized Evaluation for Failed TAVR

Sponsor: Medstar Health Research Institute

View on ClinicalTrials.gov

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

Official title: Randomized Evaluation of Valve-In-Valve Versus Explantation for Failed TAVR (REVIVE-TAVR)

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

264

Start Date

2025-03-01

Completion Date

2036-05-01

Last Updated

2025-01-24

Healthy Volunteers

No

Interventions

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.