Prosthesis Failure Clinical Trial
— REVIVE-TAVROfficial title:
Randomized Evaluation of Valve-In-Valve Versus Explantation for Failed TAVR (REVIVE-TAVR)
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
Status | Not yet recruiting |
Enrollment | 264 |
Est. completion date | May 1, 2036 |
Est. primary completion date | May 1, 2034 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Medstar Health Research Institute |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes | Time to first event of any components of the composite endpoint. | 30 days | |
Primary | Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes | Time to first event of any components of the composite endpoint. | 12 months | |
Secondary | All-cause mortality | Cardiovascular mortality, Valve-related mortality, Non-cardiovascular mortality | 30 days | |
Secondary | All-cause mortality | Cardiovascular mortality, Valve-related mortality, Non-cardiovascular mortality | 12 months | |
Secondary | Stroke | 30 days | ||
Secondary | Stroke | 12 months | ||
Secondary | Rehospitalization for cardiovascular causes | 30 days | ||
Secondary | Rehospitalization for cardiovascular causes | 12 months | ||
Secondary | Reintervention hospital length of stay (days) | 30 days | ||
Secondary | Cardiovascular mortality | 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 |
30 days | |
Secondary | Cardiovascular mortality | 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 |
12 months | |
Secondary | VARC-3 bleeding | 30 days | ||
Secondary | VARC-3 bleeding | 12 months | ||
Secondary | Vascular and access-related complications | 30 days | ||
Secondary | Vascular and access-related complications | 12 months | ||
Secondary | Cardiac structural complications | 30 days | ||
Secondary | Cardiac structural complications | 12 months | ||
Secondary | Other acute procedural and technical valve-related complications | 30 days | ||
Secondary | Other acute procedural and technical valve-related complications | 12 months | ||
Secondary | Conduction disturbance requiring permanent pacemaker implantation | 30 days | ||
Secondary | Conduction disturbance requiring permanent pacemaker implantation | 12 months | ||
Secondary | Acute kidney injury | 30 days | ||
Secondary | Acute kidney injury | 12 months | ||
Secondary | Myocardial infarction (adapted from 4th Universal, SCAI, and ARC-2 definitions) | 30 days | ||
Secondary | Myocardial infarction (adapted from 4th Universal, SCAI, and ARC-2 definitions) | 12 months | ||
Secondary | Bioprosthetic valve dysfunction (BVD) and failure (BVF) as defined by the Valve Academic Research Consortium (VARC)-3 Criteria. | 30 days | ||
Secondary | Bioprosthetic valve dysfunction (BVD) and failure (BVF) as defined by the Valve Academic Research Consortium (VARC)-3 Criteria. | 12 months | ||
Secondary | Echocardiographic assessment of prosthetic valve performance | 30 days | ||
Secondary | Echocardiographic assessment of prosthetic valve performance | 12 months | ||
Secondary | Change in NYHA class from Baseline | 30 days | ||
Secondary | Change in NYHA class from Baseline | 12 months | ||
Secondary | Change in Quality of life (KCCQ) from Baseline | 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. | 30 days | |
Secondary | Change in Quality of life (KCCQ) from Baseline | 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. | 12 months | |
Secondary | Technical Success | 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 |
30 days | |
Secondary | Device Success (for Redo-TAVR) | 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 |
30 days | |
Secondary | Safety Composite Endpoints | 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 |
30 days | |
Secondary | Technical Success | Same as above (Technical Success outcome 34) | 12 months | |
Secondary | Device Success (for Redo-TAVR) | Same as above (Device Success (for Redo-TAVR) outcome 35) | 12 months | |
Secondary | Safety Composite Endpoints | Same as above (Safety Composite Endpoints outcome 36) | 12 months |
Status | Clinical Trial | Phase | |
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