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Randomized Evaluation for Failed TAVR

NCT06400342 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2025-01-24

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Medstar Health Research Institute

    lead OTHER

Principal Investigators

  • Ron Waksman, MD · MedStar Health Research Organization

  • Toby Rogers, MD · MedStar Health Research Organization

  • Thomas MacGillivray, MD · MedStar Health Research Organization

  • Michael Reardon, MD · MedStar Health Research Organization

  • Kalyan Chitturi, DO · MedStar Health Research Organization

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2034-05-01
Completion
2036-05-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06400342 on ClinicalTrials.gov