Randomized Evaluation for Failed TAVR (REVIVE-TAVR)

MedStar Health

Status: Not yet enrolling

Conditions: Prosthetic Valve Malfunction; Prosthesis Failure; Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure

Treatments: Procedure: TAVR-explant; Device: Redo-TAVR

Study type: Interventional

Funder types: Other

Identifiers

NCT06400342

REVIVE-TAVR

Details and patient eligibility

About

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

Enrollment: 264 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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264 participants in 2 patient groups

TAVR-explant

Active Comparator group

Description:

TAVR surgical explantation

Treatment:

Procedure: TAVR-explant

Redo-TAVR

Active Comparator group

Description:

TAV-in-TAV

Treatment:

Device: Redo-TAVR