Bioprosthetic Valve FailureNCT07885761
REVIVE-FR Registry
An observational study of Bioprosthetic Valve Failure and Prosthetic Heart Valve Dysfunction, run by Institut für Pharmakologie und Präventive Medizin.
Trial summary
This registry aims to investigate treatment options for patients whose previously implanted biological aortic heart valve no longer functions properly. As patients with severe aortic stenosis are increasingly younger and at lower surgical risk, more patients may experience bioprosthetic valve failure during their… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction, Structural Valve Deterioration
- What is being tested?
- TAVI-in-SAVR (Valve-in-Valve), THV-in-THV (Redo-TAVI) and Surgical Explantation of a Failed Transcatheter Heart Valve
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2027to 15 Mar 2030
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Symptomatic adult patients (≥18 years) with a failed surgical or transcatheter aortic bioprosthesis, regardless of the failure mechanism according to VARC-3, who are indicated for elective transcatheter or surgical reintervention or managed medically based on the Heart Team's decision.
Who may be able to join
- Men and women, ≥ 18 years, with a documented indication for transcatheter or surgical reintervention] on a failed aortic bioprosthesis, or a documented diagnosis of failing THV managed medically, in one of the following four categories:
- Failed surgical bioprosthetic valve (any brand/model), with SVD or other bioprosthetic valve dysfunction, indicated for TAVI-in-SAVR; planned new valve SAPIEN 3 Ultra or SAPIEN 3 Ultra RESILIA; planned and anatomically suitable transfemoral access.
- Failed THV (any brand), with Stage II or III SVD according to VARC-3, indicated for THV-in-THV; planned new valve SAPIEN 3 Ultra or SAPIEN 3 Ultra RESILIA; planned and anatomically suitable transfemoral access.
- Failed THV (any brand), any VARC-3 failure mechanism, indicated for surgical explantation (Explant-TAVR cohort) per Heart Team decision.
- Failing THV (any brand), due to Stage II or III SVD per VARC-3 or due to infective endocarditis, managed medically - i.e., without TAVI-in-SAVR, THV-in-THV, or surgical explantation - for the Medical-Management comparator cohort.
- For all cohorts, the local Heart Team must consider the patient suitable and indicated for the planned management strategy. For retrospectively identified cases (any cohort): the index procedure was performed, or THV failure was diagnosed, on or after 1 January 2025, with data retrievable from source records, and no opposition to retrospective data use expressed by the patient or next of kin, in line with applicable French provisions. Retrospective THV-in-THV cases from REVALVE-participating centers are eligible only per the restriction described in Section 3.3. Signed informed consent is required for prospective cases; non[MZ22.1]-opposition applies to retrospective cases
Who cannot join
- Planned non-transfemoral access (e.g., transapical, transaortic, transcaval, subclavian/axillary).
- Prior mechanical aortic valve prosthesis.
- Anticipated need for a concomitant cardiac surgical procedure favoring surgical explantation over a transcatheter approach.
- Emergency/salvage (non-elective) procedure.
- Presence of LV thrombus.
- Active malignancy or ongoing chemotherapy; life expectancy below 12 months
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- Lack of informed consent.
- Concurrent or planned TAVI-in-SAVR, THV-in-THV, or surgical explantation for the same THV failure episode.
- Malignancy or ongoing chemotherapy; life expectancy below 12 months.
- Lack of informed consent or non-opposition.
About this study
Official title: REVIVE-FR: A French Multicenter, Prospective and Retrospective, Observational Registry of TAVI-in-SAVR (Valve-in-Valve), THV-in-THV (Redo-TAVI), Surgical Explantation, and Medical Management for Failed Aortic Bioprostheses
This registry aims to investigate treatment options for patients whose previously implanted biological aortic heart valve no longer functions properly. As patients with severe aortic stenosis are increasingly younger and at lower surgical risk, more patients may experience bioprosthetic valve failure during their lifetime.
Treatment options include implanting a new valve inside the existing valve using a catheter-based procedure, surgically removing the failed valve, or providing conservative medical treatment. The study will evaluate outcomes associated with these different treatment strategies to improve understanding of their benefits and risks and help guide future treatment decisions for patients with bioprosthetic valve failure.
Read the detailed description
Bioprosthetic valve failure (BVF) is an increasingly relevant clinical problem as younger patients with severe aortic stenosis undergo surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) and may outlive the expected durability of their implanted valve. BVF can result from structural valve deterioration, non-structural valve dysfunction, valve thrombosis, or endocarditis. Depending on the underlying mechanism, anatomical characteristics, surgical risk, and clinical circumstances, treatment options include transcatheter valve-in-valve implantation into a failed surgical bioprosthesis (TAVI-in-SAVR), repeat transcatheter aortic valve implantation within a failed transcatheter heart valve (THV-in-THV or redo-TAVI), surgical explantation of the failed transcatheter heart valve, or medical management without reintervention.
Evidence regarding the comparative outcomes of these management strategies remains limited, particularly for patients undergoing surgical explantation and those managed conservatively. Repeat transcatheter procedures may be associated with complications such as coronary obstruction, impaired coronary access, and elevated residual transvalvular gradients. Preprocedural computed tomography (CT) may help identify anatomical characteristics associated with these risks, including the virtual transcatheter heart valve-to-coronary distance (VTC), the virtual transcatheter heart valve-to-sinotubular junction distance (VTSTJ), and the height of the neoskirt formed by the displaced leaflets of the failed prosthesis.
REVIVE-FR is a multicenter French registry designed to collect real-world clinical data on patients with bioprosthetic valve failure managed using different treatment strategies. The registry will include patients undergoing TAVI-in-SAVR, redo-TAVI (THV-in-THV), surgical explantation of a failed transcatheter heart valve, or medical management without reintervention.
Baseline characteristics, procedural data where applicable, and follow-up information will be collected. Assessments will include clinical outcomes, echocardiographic findings, and CT-based anatomical measurements. The registry will evaluate procedural success using a VARC-3-adapted composite endpoint and safety outcomes according to VARC-3 definitions at 30 days. Clinical, echocardiographic, and CT-based outcomes will also be assessed at 1 year and, where data are available, at 2 years.
The registry aims to characterize outcomes across the different management strategies and identify patient-related, anatomical, and valve-related factors associated with complications and clinical benefit. Particular attention will be given to the mechanisms of bioprosthetic valve failure and CT-derived predictors of coronary obstruction and other complications associated with repeat transcatheter valve implantation. Patients receiving medical management without reintervention will provide a real-world reference cohort to improve understanding of the clinical course of BVF in the absence of further valve intervention.
In addition, data from the redo-TAVI cohort are intended to be combined with data from another registry to support a larger, adequately powered analysis of outcomes following THV-in-THV procedures. Overall, REVIVE-FR is intended to expand the available evidence on the management of bioprosthetic valve failure and support a better understanding of the benefits, risks, and clinical outcomes associated with the available treatment strategies. The study combines prospective enrollment with a partial, exceptional retrospective identification of eligible cases from January 2025 onward.
- Conditions
- Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction, Structural Valve Deterioration, Prosthetic Heart Valve Thrombosis, Prosthetic Valve Endocarditis
- Being tested
- TAVI-in-SAVR (Valve-in-Valve), THV-in-THV (Redo-TAVI), Surgical Explantation of a Failed Transcatheter Heart Valve, Medical management
- Keywords
- Transcatheter Aortic Valve Implantation (TAVI), TAVI-in-SAVR (ViV), THV-in-THV (redo-TAVI), Explant-TAVR, Medical-Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAVI-in-SAVR (Valve-in-Valve)Procedure or surgery
Transcatheter aortic valve implantation within a failed surgical aortic bioprosthetic valve in patients with bioprosthetic valve dysfunction, using a SAPIEN 3 Ultra or SAPIEN 3 Ultra RESILIA valve via anatomically suitable transfemoral access.
THV-in-THV (Redo-TAVI)Procedure or surgery
Repeat transcatheter aortic valve implantation within a previously implanted transcatheter heart valve with Stage II or III structural valve deterioration according to VARC-3, using a SAPIEN 3 Ultra or SAPIEN 3 Ultra RESILIA valve via anatomically suitable transfemoral access.
Surgical Explantation of a Failed Transcatheter Heart ValveProcedure or surgery
Also called THV Explantation, TAVR Explant
Surgical explantation of a previously implanted transcatheter heart valve with valve dysfunction of any mechanism, as determined by the Heart Team. Subsequent surgical aortic valve replacement may be performed according to the clinical treatment strategy
Medical managementOther
Also called Conservative Management,
Guideline-directed medical therapy and clinical surveillance for patients with a failing transcatheter heart valve due to Stage II or III structural valve deterioration according to VARC-3 or infective endocarditis, without transcatheter valve reintervention or surgical explantation
| Study group | Role | What they receive |
|---|---|---|
| TAVI-in-SAVR (ViV) patients | transfemoral THV implantation into a failed surgical bioprosthesis, any VARC-3 failure mechanism. Receives: Procedure: TAVI-in-SAVR (Valve-in-Valve) | |
| THV-in-THV (redo-TAVI) | transfemoral THV implantation into a failed THV, SVD-driven failure (VARC-3 Stage II/III) Receives: Procedure: THV-in-THV (Redo-TAVI) | |
| Explant-TAVR | surgical explantation of a failed THV, enrolled directly within REVIVE-FR (not as an external comparator) Receives: Procedure: Surgical Explantation of a Failed Transcatheter Heart Valve | |
| Medical Management | failing THV due to SVD or endocarditis, managed conservatively (i.e., without TAVI-in-SAVR, THV-in-THV, or surgical explantation); a descriptive, real-world reference cohort, not powered for statistical comparison with the interventional cohorts Receives: Other: Medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
REVIVE-FR Success at 30 Days
Proportion of patients in the TAVI-in-SAVR, THV-in-THV, and Explant-TAVR cohorts achieving REVIVE-FR success, a VARC-3-adapted composite endpoint. Success requires correct positioning of a single prosthetic heart valve in the proper anatomic location; intended valve performance (mean gradient <20 mmHg, peak velocity <3.0 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation); and freedom from mortality, coronary obstruction, unplanned coronary revascularization, and surgery or intervention related to the device. The endpoint is assessed separately for each of the three interventional cohorts and does not apply to the Medical-Management cohort.
Measured: 30 days after procedure
Early Safety at 30 Days
Determine VARC-3 defined early safety at 30 days:
- Freedom from all-cause mortality
- Freedom from all Stroke
- Freedom from all VARC type 2-4 bleeding
- Freedom from all major vascular, access-related, or cardiac structural complication
- Freedom from all acute kidney injury stage III/IV
- Freedom from all moderate/severe aortic regurgitation
- Freedom from all new permanent pacemaker implantations due to procedure-related conduction abnormalities
- Freedom from all surgery/intervention related to the device
These events will be adjudicated. Number and percentage of subjects with early safety at 30 days as per VARC-3 definition, along with individual component of the success, will be presented.
Measured: 30 days after procedure
Secondary outcomes (6)
Clinical Outcomes at 1 Year
Composite of freedom from all-cause mortality, stroke, and valve- or procedure-related rehospitalization in the TAVI-in-SAVR, THV-in-THV, and Explant-TAVR cohorts.
Measured: 1 year after procedure
Valve Durability at 1 Year
Incidence of subclinical and clinical transcatheter heart valve thrombosis and Stage II/III structural valve degeneration according to VARC-3, assessed by echocardiography and 1-year CT where available.
Measured: 1 year after procedure
All-Cause and Cardiovascular Mortality in the Medical-Management Cohort
All-cause and cardiovascular mortality will be assessed descriptively in patients managed medically for a failing transcatheter heart valve. Results will be reported as the number and percentage of patients, where appropriate. This outcome is intended for descriptive characterization and is not powered for direct comparison with the interventional cohorts.
Measured: 1 year, and optional 2 years after procedure
Heart Failure Hospitalization in the Medical-Management Cohort
Occurrence of hospitalization for heart failure during follow-up will be assessed descriptively in the Medical-Management cohort. Results will be reported descriptively and are not intended for direct statistical comparison with the interventional cohorts
Measured: 1 year; and optional 2-year after procedure
Unplanned Aortic Valve Reintervention in the Medical-Management Cohort
Occurrence of unplanned aortic valve reintervention, including crossover to TAVI-in-SAVR, THV-in-THV, or surgical explantation, will be assessed descriptively in patients initially managed medically.
Measured: 1 year; and optional 2-year after procedure
Echocardiographic Progression of Transcatheter Heart Valve Failure
Progression of transcatheter heart valve failure will be assessed descriptively using echocardiographic findings, including changes in VARC-3 structural valve degeneration stage and, in patients with endocarditis, resolution or persistence of endocarditis.
Measured: 1 year; and optional 2-year after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start15 Mar 2027 (estimated)
- Primary completion15 Apr 2029 (estimated)
- Study completion15 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioprosthetic Valve 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885761
- Sponsor's protocol ID
- REVIVE-FR-
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no individual participant data (IPD) will be shared
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REVIVE-FR: A French Multicenter, Prospective and Retrospective, Observational Registry of TAVI-in-SAVR (Valve-in-Valve), THV-in-THV (Redo-TAVI), Surgical Explantation, and Medical Management for Failed Aortic Bioprostheses
- ClinicalTrials.gov ID
- NCT07885761
- Acronym / sponsor ID
- REVIVE-FR-
- Conditions
- Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction, Structural Valve Deterioration, Prosthetic Heart Valve Thrombosis, Prosthetic Valve Endocarditis
- Keywords
- Transcatheter Aortic Valve Implantation (TAVI), TAVI-in-SAVR (ViV), THV-in-THV (redo-TAVI), Explant-TAVR, Medical-Management
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Study start
- 15 Mar 2027 (estimated)
- Primary completion
- 15 Apr 2029 (estimated)
- Study completion
- 15 Mar 2030 (estimated)
- First posted
- 21 Oct 2026 (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.
This registry aims to investigate treatment options for patients whose previously implanted biological aortic heart valve no longer functions properly. As patients with severe aortic stenosis are increasingly younger and at lower surgical risk, more patients may experience bioprosthetic valve failure during their lifetime.
Treatment options include implanting a new valve inside the existing valve using a catheter-based procedure, surgically removing the failed valve, or providing conservative medical treatment. The study will evaluate outcomes associated with these different treatment strategies to improve understanding of their benefits and risks and help guide future treatment decisions for patients with bioprosthetic valve failure.
Detailed description
Bioprosthetic valve failure (BVF) is an increasingly relevant clinical problem as younger patients with severe aortic stenosis undergo surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) and may outlive the expected durability of their implanted valve. BVF can result from structural valve deterioration, non-structural valve dysfunction, valve thrombosis, or endocarditis. Depending on the underlying mechanism, anatomical characteristics, surgical risk, and clinical circumstances, treatment options include transcatheter valve-in-valve implantation into a failed surgical bioprosthesis (TAVI-in-SAVR), repeat transcatheter aortic valve implantation within a failed transcatheter heart valve (THV-in-THV or redo-TAVI), surgical explantation of the failed transcatheter heart valve, or medical management without reintervention.
Evidence regarding the comparative outcomes of these management strategies remains limited, particularly for patients undergoing surgical explantation and those managed conservatively. Repeat transcatheter procedures may be associated with complications such as coronary obstruction, impaired coronary access, and elevated residual transvalvular gradients. Preprocedural computed tomography (CT) may help identify anatomical characteristics associated with these risks, including the virtual transcatheter heart valve-to-coronary distance (VTC), the virtual transcatheter heart valve-to-sinotubular junction distance (VTSTJ), and the height of the neoskirt formed by the displaced leaflets of the failed prosthesis.
REVIVE-FR is a multicenter French registry designed to collect real-world clinical data on patients with bioprosthetic valve failure managed using different treatment strategies. The registry will include patients undergoing TAVI-in-SAVR, redo-TAVI (THV-in-THV), surgical explantation of a failed transcatheter heart valve, or medical management without reintervention.
Baseline characteristics, procedural data where applicable, and follow-up information will be collected. Assessments will include clinical outcomes, echocardiographic findings, and CT-based anatomical measurements. The registry will evaluate procedural success using a VARC-3-adapted composite endpoint and safety outcomes according to VARC-3 definitions at 30 days. Clinical, echocardiographic, and CT-based outcomes will also be assessed at 1 year and, where data are available, at 2 years.
The registry aims to characterize outcomes across the different management strategies and identify patient-related, anatomical, and valve-related factors associated with complications and clinical benefit. Particular attention will be given to the mechanisms of bioprosthetic valve failure and CT-derived predictors of coronary obstruction and other complications associated with repeat transcatheter valve implantation. Patients receiving medical management without reintervention will provide a real-world reference cohort to improve understanding of the clinical course of BVF in the absence of further valve intervention.
In addition, data from the redo-TAVI cohort are intended to be combined with data from another registry to support a larger, adequately powered analysis of outcomes following THV-in-THV procedures. Overall, REVIVE-FR is intended to expand the available evidence on the management of bioprosthetic valve failure and support a better understanding of the benefits, risks, and clinical outcomes associated with the available treatment strategies. The study combines prospective enrollment with a partial, exceptional retrospective identification of eligible cases from January 2025 onward.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TAVI-in-SAVR (ViV) patients | – | Procedure: TAVI-in-SAVR (Valve-in-Valve)transfemoral THV implantation into a failed surgical bioprosthesis, any VARC-3 failure mechanism. |
| THV-in-THV (redo-TAVI) | – | Procedure: THV-in-THV (Redo-TAVI)transfemoral THV implantation into a failed THV, SVD-driven failure (VARC-3 Stage II/III) |
| Explant-TAVR | – | Procedure: Surgical Explantation of a Failed Transcatheter Heart Valvesurgical explantation of a failed THV, enrolled directly within REVIVE-FR (not as an external comparator) |
| Medical Management | – | Other: Medical managementfailing THV due to SVD or endocarditis, managed conservatively (i.e., without TAVI-in-SAVR, THV-in-THV, or surgical explantation); a descriptive, real-world reference cohort, not powered for statistical comparison with the interventional cohorts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic adult patients (≥18 years) with a failed surgical or transcatheter aortic bioprosthesis, regardless of the failure mechanism according to VARC-3, who are indicated for elective transcatheter or surgical reintervention or managed medically based on the Heart Team's decision.
Key inclusion criteria (6 listed)
- Men and women, ≥ 18 years, with a documented indication for transcatheter or surgical reintervention] on a failed aortic bioprosthesis, or a documented diagnosis of failing THV managed medically, in one of the following four categories:
- Failed surgical bioprosthetic valve (any brand/model), with SVD or other bioprosthetic valve dysfunction, indicated for TAVI-in-SAVR; planned new valve SAPIEN 3 Ultra or SAPIEN 3 Ultra RESILIA; planned and anatomically suitable transfemoral access.
- Failed THV (any brand), with Stage II or III SVD according to VARC-3, indicated for THV-in-THV; planned new valve SAPIEN 3 Ultra or SAPIEN 3 Ultra RESILIA; planned and anatomically suitable transfemoral access.
- Failed THV (any brand), any VARC-3 failure mechanism, indicated for surgical explantation (Explant-TAVR cohort) per Heart Team decision.
- Failing THV (any brand), due to Stage II or III SVD per VARC-3 or due to infective endocarditis, managed medically - i.e., without TAVI-in-SAVR, THV-in-THV, or surgical explantation - for the Medical-Management comparator cohort.
Key exclusion criteria (10 listed)
- Planned non-transfemoral access (e.g., transapical, transaortic, transcaval, subclavian/axillary).
- Prior mechanical aortic valve prosthesis.
- Anticipated need for a concomitant cardiac surgical procedure favoring surgical explantation over a transcatheter approach.
- Emergency/salvage (non-elective) procedure.
- Presence of LV thrombus.
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 |
|---|---|---|
| TAVI-in-SAVR (Valve-in-Valve)Transcatheter aortic valve implantation within a failed surgical aortic bioprosthetic valve in patients with bioprosthetic valve dysfunction, using a SAPIEN 3 Ultra or SAPIEN 3 Ultra RESILIA valve via anatomically suitable transfemoral access. | Procedure or surgery | TAVI-in-SAVR (ViV) patients |
| THV-in-THV (Redo-TAVI)Repeat transcatheter aortic valve implantation within a previously implanted transcatheter heart valve with Stage II or III structural valve deterioration according to VARC-3, using a SAPIEN 3 Ultra or SAPIEN 3 Ultra RESILIA valve via anatomically suitable transfemoral access. | Procedure or surgery | THV-in-THV (redo-TAVI) |
| Surgical Explantation of a Failed Transcatheter Heart ValveAlso: THV Explantation, TAVR ExplantSurgical explantation of a previously implanted transcatheter heart valve with valve dysfunction of any mechanism, as determined by the Heart Team. Subsequent surgical aortic valve replacement may be performed according to the clinical treatment strategy | Procedure or surgery | Explant-TAVR |
| Medical managementAlso: Conservative Management,Guideline-directed medical therapy and clinical surveillance for patients with a failing transcatheter heart valve due to Stage II or III structural valve deterioration according to VARC-3 or infective endocarditis, without transcatheter valve reintervention or surgical explantation | Other | Medical Management |
Primary outcome
REVIVE-FR Success at 30 Days
Time frame: 30 days after procedure
Proportion of patients in the TAVI-in-SAVR, THV-in-THV, and Explant-TAVR cohorts achieving REVIVE-FR success, a VARC-3-adapted composite endpoint. Success requires correct positioning of a single prosthetic heart valve in the proper anatomic location; intended valve performance (mean gradient <20 mmHg, peak velocity <3.0 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation); and freedom from mortality, coronary obstruction, unplanned coronary revascularization, and surgery or intervention related to the device. The endpoint is assessed separately for each of the three interventional cohorts and does not apply to the Medical-Management cohort.
Early Safety at 30 Days
Time frame: 30 days after procedure
Determine VARC-3 defined early safety at 30 days: * Freedom from all-cause mortality * Freedom from all Stroke * Freedom from all VARC type 2-4 bleeding * Freedom from all major vascular, access-related, or cardiac structural complication * Freedom from all acute kidney injury stage III/IV * Freedom from all moderate/severe aortic regurgitation * Freedom from all new permanent pacemaker implantations due to procedure-related conduction abnormalities * Freedom from all surgery/intervention related to the device These events will be adjudicated. Number and percentage of subjects with early safety at 30 days as per VARC-3 definition, along with individual component of the success, will be presented.
6 secondary outcomes
Clinical Outcomes at 1 Year
Time frame: 1 year after procedure
Valve Durability at 1 Year
Time frame: 1 year after procedure
All-Cause and Cardiovascular Mortality in the Medical-Management Cohort
Time frame: 1 year, and optional 2 years after procedure
Heart Failure Hospitalization in the Medical-Management Cohort
Time frame: 1 year; and optional 2-year after procedure
Unplanned Aortic Valve Reintervention in the Medical-Management Cohort
Time frame: 1 year; and optional 2-year after procedure
Echocardiographic Progression of Transcatheter Heart Valve Failure
Time frame: 1 year; and optional 2-year after procedure
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 21 Oct 2026.
- Individual participant dataSharing planned: No. no individual participant data (IPD) will be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bioprosthetic Valve Failure and Prosthetic Heart Valve Dysfunction, run by Institut für Pharmakologie und Präventive Medizin.
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 6 inclusion and 10 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 21 Oct 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
REVIVE-FR Success at 30 Days (time frame: 30 days after procedure). 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 21 Oct 2026.