An interventional study of TAVR-explant and Redo-TAVR in Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure, Prosthetic Valve Malfunction and Prosthesis Failure, sponsored by Medstar Health Research Institute. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by Medstar Health Research Institute · Not applicable, Interventional, and Treatment
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
119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.
This study's planned enrollment of 264 is above the median of 36 across 69 interventional studies indexed under Prosthesis Failure.
Browse Prosthesis Failure studies →Medstar Health Research Institute is the lead sponsor of 161 studies on the registry; 31 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 7 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Coronary obstruction risk:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TAVR surgical explantation
Procedure: TAVR-explant
TAV-in-TAV
Device: Redo-TAVR
Surgical explantation of failed THV followed by surgical aortic valve replacement and any other cardiac surgeries deemed necessary.
Repeat transcatheter aortic valve implantation within a failed THV.
Also known as: Valve-in-Valve, TAV-in-TAV
Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes
Time to first event of any components of the composite endpoint.
Time frame: 30 days
Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes
Time to first event of any components of the composite endpoint.
Time frame: 12 months
All-cause mortality
Cardiovascular mortality, Valve-related mortality, Non-cardiovascular mortality
Time frame: 30 days
All-cause mortality
Cardiovascular mortality, Valve-related mortality, Non-cardiovascular 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
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
Time frame: 30 days
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
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
Vascular and access-related complications
Time frame: 12 months
Cardiac structural complications
Time frame: 30 days
Cardiac structural complications
Time frame: 12 months
Other acute procedural and technical valve-related complications
Time frame: 30 days
Other acute procedural and technical valve-related complications
Time frame: 12 months
Conduction disturbance requiring permanent pacemaker implantation
Time frame: 30 days
Conduction disturbance requiring permanent pacemaker implantation
Time frame: 12 months
Acute kidney injury
Time frame: 30 days
Acute kidney injury
Time frame: 12 months
Myocardial infarction (adapted from 4th Universal, SCAI, and ARC-2 definitions)
Time frame: 30 days
Myocardial infarction (adapted from 4th Universal, SCAI, and ARC-2 definitions)
Time frame: 12 months
Bioprosthetic valve dysfunction (BVD) and failure (BVF) as defined by the Valve Academic Research Consortium (VARC)-3 Criteria.
Time frame: 30 days
Bioprosthetic valve dysfunction (BVD) and failure (BVF) as defined by the Valve Academic Research Consortium (VARC)-3 Criteria.
Time frame: 12 months
Echocardiographic assessment of prosthetic valve performance
Time frame: 30 days
Echocardiographic assessment of prosthetic valve performance
Time frame: 12 months
Change in NYHA class from Baseline
Time frame: 30 days
Change in NYHA class from Baseline
Time frame: 12 months
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.
Time frame: 30 days
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.
Time frame: 12 months
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
Time frame: 30 days
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
Time frame: 30 days
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
Time frame: 30 days
Technical Success
Same as above (Technical Success outcome 34)
Time frame: 12 months
Device Success (for Redo-TAVR)
Same as above (Device Success (for Redo-TAVR) outcome 35)
Time frame: 12 months
Safety Composite Endpoints
Same as above (Safety Composite Endpoints outcome 36)
Time frame: 12 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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