Prosthesis Failure, Prosthetic Valve Malfunction, Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure
Conditions
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
Interventions
PROCEDURETAVR-explant
Surgical explantation of failed THV followed by surgical aortic valve replacement and any other cardiac surgeries deemed necessary.
DEVICERedo-TAVR
Repeat transcatheter aortic valve implantation within a failed THV.
Sponsors
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes | 30 days | Time to first event of any components of the composite endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stroke | 30 days | — |
| Rehospitalization for cardiovascular causes | 30 days | — |
| Reintervention hospital length of stay (days) | 30 days | — |
| Cardiovascular mortality | 30 days | Death meeting one of the following criteria: * related to heart failure, cardiogenic shock, bioprosthetic valve dysfunction, myocardial infarction, stroke, thromboembolism, bleeding, tamponade, vascular complication, arrhythmia or conduction system disturbances, cardiovascular infection (e.g. mediastinitis, endocarditis), or other clear cardiovascular cause * Intraprocedural death * Sudden death * Death of unknown cause Valve-related mortality \- Death presumed to be related to bioprosthetic valve dysfunction |
| VARC-3 bleeding | 30 days | — |
| Vascular and access-related complications | 30 days | — |
| Cardiac structural complications | 30 days | — |
| Other acute procedural and technical valve-related complications | 30 days | — |
| Conduction disturbance requiring permanent pacemaker implantation | 30 days | — |
| All-cause mortality | 30 days | Cardiovascular mortality, Valve-related mortality, Non-cardiovascular mortality |
| Myocardial infarction (adapted from 4th Universal, SCAI, and ARC-2 definitions) | 30 days | — |
| Bioprosthetic valve dysfunction (BVD) and failure (BVF) as defined by the Valve Academic Research Consortium (VARC)-3 Criteria. | 30 days | — |
| Echocardiographic assessment of prosthetic valve performance | 30 days | — |
| Change in NYHA class from Baseline | 30 days | — |
| Change in Quality of life (KCCQ) from Baseline | 30 days | The KCCQ has a 0-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. |
| Technical Success | 30 days | * Freedom from mortality * Successful access, delivery of the device and retrieval of the delivery system * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication |
| Device Success (for Redo-TAVR) | 30 days | * Technical success * Freedom from mortality * Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication * Intended performance of the valve |
| Safety Composite Endpoints | 30 days | * Early safety, which includes freedom from all-cause mortality, all stroke, VARC type 2-4 bleeding, major vascular, access-related or cardiac structural complication, acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure-related conduction abnormalities and surgery or intervention related to the device. * Clinical efficacy * Valve-related long-term clinical efficacy |
| Acute kidney injury | 30 days | — |
Contacts
Primary ContactKassandra Lopez
Backup ContactJake Sutton
Outcome results
None listed