REVIVE-FR Registry

NCT07885761 | Not Yet Recruiting

• 1 other identifier: REVIVE-FR-
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  30 days after procedure

Secondary Outcomes (6)

• Clinical Outcomes at 1 Year

  1 year after procedure

• Valve Durability at 1 Year

  1 year after procedure

• All-Cause and Cardiovascular Mortality in the Medical-Management Cohort

  1 year, and optional 2 years after procedure

• Heart Failure Hospitalization in the Medical-Management Cohort

  1 year; and optional 2-year after procedure

• Unplanned Aortic Valve Reintervention in the Medical-Management Cohort

  1 year; and optional 2-year after procedure

Study Arms (4)

TAVI-in-SAVR (ViV) patients

transfemoral THV implantation into a failed surgical bioprosthesis, any VARC-3 failure mechanism.

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)

Procedure: THV-in-THV (Redo-TAVI)

Explant-TAVR

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

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

Other: Medical management

Interventions

TAVI-in-SAVR (Valve-in-Valve) PROCEDURE

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.

TAVI-in-SAVR (ViV) patients

THV-in-THV (Redo-TAVI) PROCEDURE

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.

THV-in-THV (redo-TAVI)

Surgical Explantation of a Failed Transcatheter Heart Valve PROCEDURE

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

Explant-TAVR

Medical management OTHER

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,

Medical Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Institut für Pharmakologie und Präventive Medizin: lead

MeSH Terms

Interventions

Practice Management, Medical; Conservative Treatment

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration; Therapeutics

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): March 15, 2027
• Primary Completion (Estimated): April 15, 2029
• Study Completion (Estimated): March 15, 2030
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share