Clinical trial NCT06400342: Randomized Evaluation for Failed TAVR
Official title: Randomized Evaluation of Valve-In-Valve Versus Explantation for Failed TAVR (REVIVE-TAVR)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure
Prosthetic Valve Malfunction
Prosthesis Failure
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects deemed eligible for both redo-TAVR and TAVR-explant by the Heart Team for the treatment of failed THV will be randomized on a 1:1 basis to either redo-TAVR or TAVR-explant.
Primary purpose: TREATMENT

Brief 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


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.

Primary outcomes:
measure: Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes
timeFrame: 30 days
measure: Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes
timeFrame: 12 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: 30 days
measure: All-cause mortality
timeFrame: 12 months
measure: Stroke
timeFrame: 30 days
measure: Stroke
timeFrame: 12 months
measure: Rehospitalization for cardiovascular causes
timeFrame: 30 days
measure: Rehospitalization for cardiovascular causes
timeFrame: 12 months
measure: Reintervention hospital length of stay (days)
timeFrame: 30 days
measure: Cardiovascular mortality
timeFrame: 30 days
measure: Cardiovascular mortality
timeFrame: 12 months
measure: VARC-3 bleeding
timeFrame: 30 days
measure: VARC-3 bleeding
timeFrame: 12 months
measure: Vascular and access-related complications
timeFrame: 30 days
measure: Vascular and access-related complications
timeFrame: 12 months
measure: Cardiac structural complications
timeFrame: 30 days
measure: Cardiac structural complications
timeFrame: 12 months
measure: Other acute procedural and technical valve-related complications
timeFrame: 30 days
measure: Other acute procedural and technical valve-related complications
timeFrame: 12 months
measure: Conduction disturbance requiring permanent pacemaker implantation
timeFrame: 30 days
measure: Conduction disturbance requiring permanent pacemaker implantation
timeFrame: 12 months
measure: Acute kidney injury
timeFrame: 30 days
measure: Acute kidney injury
timeFrame: 12 months
measure: Myocardial infarction (adapted from 4th Universal, SCAI, and ARC-2 definitions)
timeFrame: 30 days
measure: Myocardial infarction (adapted from 4th Universal, SCAI, and ARC-2 definitions)
timeFrame: 12 months
measure: Bioprosthetic valve dysfunction (BVD) and failure (BVF) as defined by the Valve Academic Research Consortium (VARC)-3 Criteria.
timeFrame: 30 days
measure: Bioprosthetic valve dysfunction (BVD) and failure (BVF) as defined by the Valve Academic Research Consortium (VARC)-3 Criteria.
timeFrame: 12 months
measure: Echocardiographic assessment of prosthetic valve performance
timeFrame: 30 days
measure: Echocardiographic assessment of prosthetic valve performance
timeFrame: 12 months
measure: Change in NYHA class from Baseline
timeFrame: 30 days
measure: Change in NYHA class from Baseline
timeFrame: 12 months
measure: Change in Quality of life (KCCQ) from Baseline
timeFrame: 30 days
measure: Change in Quality of life (KCCQ) from Baseline
timeFrame: 12 months
measure: Technical Success
timeFrame: 30 days
measure: Device Success (for Redo-TAVR)
timeFrame: 30 days
measure: Safety Composite Endpoints
timeFrame: 30 days
measure: Technical Success
timeFrame: 12 months
measure: Device Success (for Redo-TAVR)
timeFrame: 12 months
measure: Safety Composite Endpoints
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: MedStar Health Research Organization
name: Ron Waksman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MedStar Health Research Organization
name: Toby Rogers, MD
role: STUDY_CHAIR
affiliation: MedStar Health Research Organization
name: Thomas MacGillivray, MD
role: STUDY_CHAIR
affiliation: MedStar Health Research Organization
name: Michael Reardon, MD
role: STUDY_CHAIR
affiliation: MedStar Health Research Organization
name: Kalyan Chitturi, DO
role: STUDY_CHAIR
References: