An observational study in Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction and Structural Valve Deterioration, sponsored by Institut für Pharmakologie und Präventive Medizin. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Institut für Pharmakologie und Präventive Medizin · Observational
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.
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.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's planned enrollment of 200 is below the median of 225 across 82 observational studies indexed under Endocarditis.
Browse Endocarditis studies →Institut für Pharmakologie und Präventive Medizin is the lead sponsor of 30 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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.
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:
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 is required for prospective cases; non[MZ22.1]-opposition applies to retrospective cases
Exclusion Criteria - TAVI-in-SAVR and THV-in-THV Cohorts:
Exclusion Criteria - Medical-Management Cohort:
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
transfemoral THV implantation into a failed surgical bioprosthesis, any VARC-3 failure mechanism.
Procedure: TAVI-in-SAVR (Valve-in-Valve)
transfemoral THV implantation into a failed THV, SVD-driven failure (VARC-3 Stage II/III)
Procedure: THV-in-THV (Redo-TAVI)
surgical explantation of a failed THV, enrolled directly within REVIVE-FR (not as an external comparator)
Procedure: Surgical Explantation of a Failed Transcatheter Heart Valve
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
Other: Medical management
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.
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 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
Also known as: THV Explantation, TAVR Explant
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
Also known as: Conservative Management,
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.
Time frame: 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.
Time frame: 30 days after procedure
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 1 year; and optional 2-year after procedure
No study locations are listed for this record.
Plan to share: No — no individual participant data (IPD) will be shared
No publications or documents are linked to this record.
Start is estimated for Mar 2027; primary completion for Apr 2029, 25 months later.
Of 36 observational studies under Endocarditis, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 36. This study's planned 25 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Institut für Pharmakologie und Präventive Medizin