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

March 5, 2026 updated by: Heart Center Leipzig - University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
890

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 5 years
based on VARC-3
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Each of the individual components of the primary composite endpoint
Time Frame: 5 years
based on VARC-3
5 years
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)
5 years
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)
5 years
New York Heart Association classification III or IV
Time Frame: 5 years
New York Heart Association classification (qualitative variable; III or IV)
5 years
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.
5 years
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).
5 years
Six-minute walk test
Time Frame: 5 years
six-minute walk test (quantitative continuous variable)
5 years
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heart Center Leipzig - University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Leipzig
Helios Health Institute GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Borger, University Leipzig

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2033

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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