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Not yet recruiting NCT06400342

Randomized Evaluation for Failed TAVR

No phase Interventional Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure Prosthetic Valve Malfunction Prosthesis Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TAVR-explant, Redo-TAVR.
Who it may be relevant to
Registry conditions: Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure, Prosthetic Valve Malfunction, Prosthesis Failure. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Primary outcome measures

  • Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes [Time frame: 30 days]
  • Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes [Time frame: 12 months]
Secondary outcome measures (12)
  • All-cause mortality [Time frame: 30 days]
  • All-cause mortality [Time frame: 12 months]
  • Stroke [Time frame: 30 days]
  • Stroke [Time frame: 12 months]
  • Rehospitalization for cardiovascular causes [Time frame: 30 days]
  • Rehospitalization for cardiovascular causes [Time frame: 12 months]
  • Reintervention hospital length of stay (days) [Time frame: 30 days]
  • Cardiovascular mortality [Time frame: 30 days]
  • Cardiovascular mortality [Time frame: 12 months]
  • VARC-3 bleeding [Time frame: 30 days]
  • VARC-3 bleeding [Time frame: 12 months]
  • Vascular and access-related complications [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

  • Heart Team has confirmed eligibility for both TAVR-explant and redo-TAVR for failed THV
  • Subject is symptomatic from their failed THV, as demonstrated by NYHA Functional Class ≥II
  • Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
  • Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.

Exclusion criteria

  • Ongoing sepsis, including active endocarditis;
  • Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);
  • Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams;
  • Pregnancy or intent to become pregnant for the next 12 months;

Coronary obstruction risk:

\- Patients at risk of coronary obstruction may be enrolled into the randomized cohort if the operators determine that redo-TAVR can be safely accomplished with leaflet modification or other coronary protection strategies.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06400342 · REVIVE-TAVR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗