Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) FailureREVIVE-TAVRNCT06400342
Randomized Evaluation for Failed TAVR
A study testing TAVR-explant and Redo-TAVR in people with Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure and Prosthetic Valve Malfunction, run by Medstar Health Research Institute.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure, Prosthetic Valve Malfunction, Prosthesis Failure
- What is being tested?
- TAVR-explant and Redo-TAVR
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 May 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
- Conditions
- Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure, Prosthetic Valve Malfunction, Prosthesis Failure
- Being tested
- TAVR-explant, Redo-TAVR
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVR-explantProcedure or surgery
Surgical explantation of failed THV followed by surgical aortic valve replacement and any other cardiac surgeries deemed necessary.
Redo-TAVRDevice
Also called Valve-in-Valve, TAV-in-TAV
Repeat transcatheter aortic valve implantation within a failed THV.
| Study group | Role | What they receive |
|---|---|---|
| TAVR-explant | Active comparator | TAVR surgical explantation Receives: Procedure: TAVR-explant |
| Redo-TAVR | Active comparator | TAV-in-TAV Receives: Device: Redo-TAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes
Time to first event of any components of the composite endpoint.
Measured: 30 days
Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes
Time to first event of any components of the composite endpoint.
Measured: 12 months
Secondary outcomes (37)
All-cause mortality
Cardiovascular mortality, Valve-related mortality, Non-cardiovascular mortality
Measured: 30 days
All-cause mortality
Cardiovascular mortality, Valve-related mortality, Non-cardiovascular mortality
Measured: 12 months
Stroke
Measured: 30 days
Stroke
Measured: 12 months
Rehospitalization for cardiovascular causes
Measured: 30 days
Rehospitalization for cardiovascular causes
Measured: 12 months
Reintervention hospital length of stay (days)
Measured: 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
Measured: 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
Measured: 12 months
VARC-3 bleeding
Measured: 30 days
VARC-3 bleeding
Measured: 12 months
Vascular and access-related complications
Measured: 30 days
Vascular and access-related complications
Measured: 12 months
Cardiac structural complications
Measured: 30 days
Cardiac structural complications
Measured: 12 months
Other acute procedural and technical valve-related complications
Measured: 30 days
Other acute procedural and technical valve-related complications
Measured: 12 months
Conduction disturbance requiring permanent pacemaker implantation
Measured: 30 days
Conduction disturbance requiring permanent pacemaker implantation
Measured: 12 months
Acute kidney injury
Measured: 30 days
Acute kidney injury
Measured: 12 months
Myocardial infarction (adapted from 4th Universal, SCAI, and ARC-2 definitions)
Measured: 30 days
Myocardial infarction (adapted from 4th Universal, SCAI, and ARC-2 definitions)
Measured: 12 months
Bioprosthetic valve dysfunction (BVD) and failure (BVF) as defined by the Valve Academic Research Consortium (VARC)-3 Criteria.
Measured: 30 days
Bioprosthetic valve dysfunction (BVD) and failure (BVF) as defined by the Valve Academic Research Consortium (VARC)-3 Criteria.
Measured: 12 months
Echocardiographic assessment of prosthetic valve performance
Measured: 30 days
Echocardiographic assessment of prosthetic valve performance
Measured: 12 months
Change in NYHA class from Baseline
Measured: 30 days
Change in NYHA class from Baseline
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days
Technical Success
Same as above (Technical Success outcome 34)
Measured: 12 months
Device Success (for Redo-TAVR)
Same as above (Device Success (for Redo-TAVR) outcome 35)
Measured: 12 months
Safety Composite Endpoints
Same as above (Safety Composite Endpoints outcome 36)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 Mar 2025 (estimated)
- Primary completion1 May 2034 (estimated)
- Study completion1 May 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ron Waksman, MD, Principal investigator, MedStar Health Research OrganizationToby Rogers, MD, Study chair, MedStar Health Research OrganizationThomas MacGillivray, MD, Study chair, MedStar Health Research OrganizationMichael Reardon, MD, Study chair, MedStar Health Research OrganizationKalyan Chitturi, DO, Study chair, MedStar Health Research Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400342
- Sponsor's protocol ID
- REVIVE-TAVR
- Acronym
- REVIVE-TAVR
- Status last verified
- Jan 2025
- First submitted
- 25 Mar 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of Valve-In-Valve Versus Explantation for Failed TAVR (REVIVE-TAVR)
- ClinicalTrials.gov ID
- NCT06400342
- Acronym / sponsor ID
- REVIVE-TAVR / REVIVE-TAVR
- Conditions
- Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure, Prosthetic Valve Malfunction, Prosthesis Failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 May 2034 (estimated)
- Study completion
- 1 May 2036 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| TAVR-explant | Active comparator | Procedure: TAVR-explantTAVR surgical explantation |
| Redo-TAVR | Active comparator | Device: Redo-TAVRTAV-in-TAV |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAVR-explantSurgical explantation of failed THV followed by surgical aortic valve replacement and any other cardiac surgeries deemed necessary. | Procedure or surgery | TAVR-explant |
| Redo-TAVRAlso: Valve-in-Valve, TAV-in-TAVRepeat transcatheter aortic valve implantation within a failed THV. | Device | Redo-TAVR |
Primary outcome
Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes
Time frame: 30 days
Time to first event of any components of the composite endpoint.
Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes
Time frame: 12 months
Time to first event of any components of the composite endpoint.
37 secondary outcomes
All-cause mortality
Time frame: 30 days
All-cause 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
Time frame: 30 days
Cardiovascular mortality
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
Time frame: 30 days
Change in Quality of life (KCCQ) from Baseline
Time frame: 12 months
Technical Success
Time frame: 30 days
Device Success (for Redo-TAVR)
Time frame: 30 days
Safety Composite Endpoints
Time frame: 30 days
Technical Success
Time frame: 12 months
Device Success (for Redo-TAVR)
Time frame: 12 months
Safety Composite Endpoints
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure
RecruitingObservational study
The ReTAVI Prospective Observational Registry
Structural Valve Deterioration, Structural Valve Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ron Waksman, MD principal investigator
MedStar Health Research Organization
Toby Rogers, MD study chair
MedStar Health Research Organization
Thomas MacGillivray, MD study chair
MedStar Health Research Organization
Questions about this trial
What is this clinical trial studying?
A study testing TAVR-explant and Redo-TAVR in people with Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure and Prosthetic Valve Malfunction, run by Medstar Health Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kassandra Lopez (202-877-2452, kassandra.lopez@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite: All-cause mortality, stroke, and rehospitalization for cardiovascular causes (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025; AzTrials last refreshed its copy on 27 Oct 2026.