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NOT YET RECRUITING

NCT07885761

REVIVE-FR Registry

Sponsor: Institut für Pharmakologie und Präventive Medizin

View on ClinicalTrials.gov

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 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2027-03-15

Completion Date

2030-03-15

Last Updated

2026-10-21

Healthy Volunteers

Conditions

Bioprosthetic Valve Failure Prosthetic Heart Valve Dysfunction Structural Valve Deterioration Prosthetic Heart Valve Thrombosis Prosthetic Valve Endocarditis

Interventions

PROCEDURE

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

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

Surgical Explantation of a Failed Transcatheter Heart Valve

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

OTHER

Medical 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

Inclusion Criteria: 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 Exclusion Criteria - TAVI-in-SAVR and THV-in-THV Cohorts: * 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 * Lack of informed consent. Exclusion Criteria - Medical-Management Cohort: * 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.

Clinical Research Directory

REVIVE-FR Registry

Summary

Key Details

Conditions

Interventions

Eligibility Criteria