Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07462624

REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Degenerative Aortic Valve Disease

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

    Time frame: 5 years

    based on VARC-3

Secondary outcomes

  1. Each of the individual components of the primary composite endpoint

    Time frame: 5 years

    based on VARC-3

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

    Time frame: 5 years

    VARC-3-based conduction disturbances and arrhythmia (qualitative variable; yes or no)

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

    Time frame: 5 years

    BARC-based bleeding complications (qualitative ordinal variable; 3b-5)

  4. New York Heart Association classification III or IV

    Time frame: 5 years

    New York Heart Association classification (qualitative variable; III or IV)

  5. Health status evaluated by the Kansas City Cardiomyopathy Questionnaire

    Time frame: 5 years

    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.

  6. Health status evaluated by the SF-36 questionnaire

    Time frame: 5 years

    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).

  7. Six-minute walk test

    Time frame: 5 years

    six-minute walk test (quantitative continuous variable)

  8. Treatment Costs per quality adjusted life year Assessment of Safety

    Time frame: 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthias Raschpichler

CONTACT

[email protected]

Michael Borger

CONTACT

[email protected]

03418650

Sponsors and collaborators

Lead sponsor

Heart Center Leipzig - University Hospital

Other

Collaborators

  • Helios Health Institute GmbH
  • University of Leipzig

Registry information

Official study title

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

Acronym: REPEAT

Important dates

Study start
2025
Primary completion
2033
Study completion
2033
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.