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NCT07885761Not yet recruiting

REVIVE-FR Registry

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

Source: ClinicalTrials.gov · Last updated 21 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
13 Oct 2026
Start date
15 Mar 2027
Primary completion date
15 Apr 2029
Lead sponsor
Institut für Pharmakologie und Präventive Medizin
NCT number
NCT07885761

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 15 Mar 2027 to the primary completion date, 15 Apr 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior mechanical aortic valve prosthesis.
  • Anticipated need for a concomitant cardiac surgical procedure favoring surgical explantation over a transcatheter approach.
  • Concurrent or planned TAVI-in-SAVR, THV-in-THV, or surgical explantation for the same THV failure episode.

Other illness

  • Active malignancy or ongoing chemotherapy; life expectancy below 12 months
  • Malignancy or ongoing chemotherapy; life expectancy below 12 months.

Other

  • Planned non-transfemoral access (e.g., transapical, transaortic, transcaval, subclavian/axillary).
  • Emergency/salvage (non-elective) procedure.
  • Presence of LV thrombus.
  • Lack of informed consent.
  • Lack of informed consent or non-opposition.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.