REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT) (REPEAT)

REpeat Intervention for Failed Surgical BioProsthEtic AorTic Valves (REPEAT): A Multicenter Randomized Trial Comparing Redo Surgical Aortic Valve Replacement to Valve-in-Valve Transcatheter Aortic Valve Replacement

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.

Study Overview

• Status: Recruiting
• Conditions: Degenerative Aortic Valve Disease
• Intervention / Treatment: Procedure: Transfemoral transcatheter valve-in-valve implantation; Procedure: Surgical redo aortic valve replacement

• Study Type: Interventional
• Enrollment (Estimated): 890
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Borger; Phone Number: 03418650; Email: Michael.Borger@helios-gesundheit.de
• Study Contact Backup: Name: Matthias Raschpichler; Email: matthias.raschpichler@helios-gesundheit.de

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04289
      • Recruiting
      • Herzzentrum Leipzig GmbH
      • Contact: Michael Borger; Phone Number: 03418650; Email: Michael.Borger@helios-gesundheit.de
      • Contact: Matthias Raschpichler; Email: matthias.raschpichler@helios-gesundheit.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ViV-TAVR; 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; 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.
Active Comparator: redoAVR; 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; Surgical rAVR serves as the control intervention. The patient's degenerated aortic bioprosthesis is replaced using conventional open-heart surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Each of the individual components of the primary composite endpoint	based on VARC-3	5 years
Valve Academic Research Consortium-3 (VARC-3)1-based conduction disturbances and arrhythmia	VARC-3-based conduction disturbances and arrhythmia (qualitative variable; yes or no)	5 years
Wound and bleeding complications (based on Bleeding Academic Research Consortium class 3b-5)	BARC-based bleeding complications (qualitative ordinal variable; 3b-5)	5 years
New York Heart Association classification III or IV	New York Heart Association classification (qualitative variable; III or IV)	5 years
Health status evaluated by the Kansas City Cardiomyopathy Questionnaire	The KCCQ score, short for Kansas City Cardiomyopathy Questionnaire score, is a disease-specific, patient-reported score used to assess health status in heart failure. It consists of 23 items that assess symptoms, quality of life, and the impact of the disease on physical and social functioning over the past two weeks. Each area is transformed on a scale of 0 to 100, with higher scores indicating better health status. A difference of 5 points is considered clinically relevant, both for improvement and deterioration.	5 years
Health status evaluated by the SF-36 questionnaire	The SF-36 measures 3 aspects of health (functional status, wellbeing, overall evaluation of health) using 8 separate scales. Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, i.e., severe disability) to 100 (no health restrictions).	5 years
Six-minute walk test	six-minute walk test (quantitative continuous variable)	5 years
Treatment Costs per quality adjusted life year Assessment of Safety	This data will be collected for participating sites of countries in which this data is available. In patient costs will be measured through the collection of hospital billing and resource utilization information.	5 years

Collaborators and Investigators

• Sponsor: Heart Center Leipzig - University Hospital
• Collaborators: University of Leipzig; Helios Health Institute GmbH
• Investigators: Principal Investigator: Michael Borger, University Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2025
• Primary Completion (Estimated): September 30, 2033
• Study Completion (Estimated): September 30, 2033

Study Registration Dates

• First Submitted: January 19, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2024-0081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No