REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)

NCT07462624 | Recruiting DMC

• 1 other identifier: 2024-0081
• Study Type: interventional
• Target: 890
• Locations: 1 country
• Sites: 1

Brief Summary

The overall hypothesis is that redo aortic valve replacement (rAVR) is superior to valve-invalve transcatheter aortic valve replacement (ViV-TAVR) for the composite endpoint of freedom from all-cause mortality, all-cause stroke, myocardial infarction, and rehospitalization for heart failure or aortic valve re-intervention at 5 years.

Conditions

Degenerative Aortic Valve Disease

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will be a composite endpoint including all-cause mortality, all-cause stroke, myocardial infarction, and re-hospitalization for heart failure or aortic valve reintervention at 5 years.

  based on VARC-3

  5 years

Secondary Outcomes (8)

• Each of the individual components of the primary composite endpoint

  5 years

• Valve Academic Research Consortium-3 (VARC-3)1-based conduction disturbances and arrhythmia

  5 years

• Wound and bleeding complications (based on Bleeding Academic Research Consortium class 3b-5)

  5 years

• New York Heart Association classification III or IV

  5 years

• Health status evaluated by the Kansas City Cardiomyopathy Questionnaire

  5 years

Study Arms (2)

ViV-TAVR

EXPERIMENTAL

The intervention under investigation is transcatheter - preferably transfemoral - ViV-TAVR applied for degenerated surgical aortic bioprostheses with an indication for re-intervention in patients at low-to-intermediate surgical risk. An aortic transcatheter bioprosthesis is implanted into the degenerated surgical aortic bioprosthesis.

Procedure: Transfemoral transcatheter valve-in-valve implantation

redoAVR

ACTIVE COMPARATOR

Surgical redoAVR serves as the control intervention. The patient's degenerated aortic bioprosthesis is replaced using conventional open-heart surgery.

Procedure: Surgical redo aortic valve replacement

Interventions

Transfemoral transcatheter valve-in-valve implantation PROCEDURE

The intervention under investigation is transcatheter \- preferably transfemoral - ViV-TAVR applied for degenerated surgical aortic bioprostheses with an indication for re-intervention in patients at low-to intermediate surgical risk. An aortic transcatheter bioprosthesis is implanted into the degenerated surgical aortic bioprosthesis.

ViV-TAVR

Surgical redo aortic valve replacement PROCEDURE

Surgical rAVR serves as the control intervention. The patient's degenerated aortic bioprosthesis is replaced using conventional open-heart surgery.

redoAVR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication for repeat intervention for failed surgical aortic bioprosthesis due to structural valve deterioration (SVD; prosthesis stenosis and/or transprosthetic insufficiency);
• Low to intermediate surgical risk (i.e., Society of Thoracic Surgeons (STS) predicted risk of mortality of \< 8%);
• Age \> 18 and \< 75 years;
• Both rAVR and ViV-TAVR are judged to be reasonable options based on evaluation by the local Heart Team

You may not qualify if:

• Multiple valvular disease requiring surgical intervention;
• High-risk coronary anatomy resulting in increased risk of coronary obstruction following ViV-TAVR prosthesis deployment;
• Complex coronary artery disease requiring revascularization (unprotected left main coronary artery, Syntax score \> 32) and Heart Team assessment that optimal revascularization cannot be performed;
• Failing valve with evidence of bacterial endocarditis or evidence of non-structural valve deterioration (e.g., paravalvular leak, thrombosis);
• Increased post-procedural gradients (mean \> 20 mmHg) or severe patient-prosthesis mismatch (PPM, indexed effective orifice area \< 0.65 cm2/m2) at discharge from index aortic valve replacement (AVR) procedure;
• Patients who choose to receive a mechanical AVR.

Sponsors & Collaborators

• Heart Center Leipzig - University Hospital: lead
• University of Leipzig: collaborator
• Helios Health Institute GmbH: collaborator

Study Sites (1)

Herzzentrum Leipzig GmbH

Leipzig, Saxony, 04289, Germany

RECRUITING

Study Officials

• Michael Borger

  University Leipzig

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Borger

CONTACT

03418650; Michael.Borger@helios-gesundheit.de

Matthias Raschpichler

CONTACT

matthias.raschpichler@helios-gesundheit.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: March 10, 2026
• Study Start: November 10, 2025
• Primary Completion (Estimated): September 30, 2033
• Study Completion (Estimated): September 30, 2033
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)