Degenerative Aortic Valve DiseaseREPEATNCT07462624
REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)
A study testing Transfemoral transcatheter valve-in-valve implantation and Surgical redo aortic valve replacement in people with Degenerative Aortic Valve Disease, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Degenerative Aortic Valve Disease
- What is being tested?
- Transfemoral transcatheter valve-in-valve implantation and Surgical redo aortic valve replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 890 participants
- Where
- 1 siteGermany
- Study dates
- 10 Nov 2025to 30 Sep 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Matthias Raschpichler contact
Germany1 site, 1 recruiting
- Recruiting
Herzzentrum Leipzig GmbH
Leipzig, Saxony, 04289
Michael Borger, 03418650, Michael.Borger@helios-gesundheit.de
Matthias Raschpichler, matthias.raschpichler@helios-gesundheit.de
About this study
Official 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
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
- Being tested
- Transfemoral transcatheter valve-in-valve implantation, Surgical redo aortic valve replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfemoral transcatheter valve-in-valve implantationProcedure or surgery
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 replacementProcedure or surgery
Surgical rAVR serves as the control intervention. The patient's degenerated aortic bioprosthesis is replaced using conventional open-heart surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Surgical redo aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (8)
Each of the individual components of the primary composite endpoint
based on VARC-3
Measured: 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)
Measured: 5 years
Wound and bleeding complications (based on Bleeding Academic Research Consortium class 3b-5)
BARC-based bleeding complications (qualitative ordinal variable; 3b-5)
Measured: 5 years
New York Heart Association classification III or IV
New York Heart Association classification (qualitative variable; III or IV)
Measured: 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.
Measured: 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).
Measured: 5 years
Six-minute walk test
six-minute walk test (quantitative continuous variable)
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start10 Nov 2025
- Primary completion30 Sep 2033 (estimated)
- Study completion30 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Aortic Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 890 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart Center Leipzig - University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leipzig, Helios Health Institute GmbH
- Responsible party
- Sponsor
- Investigators
- Michael Borger, Principal investigator, University Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462624
- Sponsor's protocol ID
- 2024-0081
- Acronym
- REPEAT
- Status last verified
- Mar 2026
- First submitted
- 19 Jan 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07462624
- Acronym / sponsor ID
- REPEAT / 2024-0081
- Conditions
- Degenerative Aortic Valve Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 890 participants (estimated)
- Lead sponsor
- Heart Center Leipzig - University HospitalUniversity, hospital or other
- Collaborators
- University of Leipzig, Helios Health Institute GmbH
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 30 Sep 2033 (estimated)
- Study completion
- 30 Sep 2033 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ViV-TAVR | Experimental | Procedure: Transfemoral transcatheter valve-in-valve implantationThe 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. |
| redoAVR | Active comparator | Procedure: Surgical redo aortic valve replacementSurgical redoAVR serves as the control intervention. The patient's degenerated aortic bioprosthesis is replaced using conventional open-heart surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transfemoral transcatheter valve-in-valve implantationThe 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 or surgery | ViV-TAVR |
| Surgical redo aortic valve replacementSurgical rAVR serves as the control intervention. The patient's degenerated aortic bioprosthesis is replaced using conventional open-heart surgery. | Procedure or surgery | redoAVR |
Primary outcome
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
8 secondary outcomes
Each of the individual components of the primary composite endpoint
Time frame: 5 years
Valve Academic Research Consortium-3 (VARC-3)1-based conduction disturbances and arrhythmia
Time frame: 5 years
Wound and bleeding complications (based on Bleeding Academic Research Consortium class 3b-5)
Time frame: 5 years
New York Heart Association classification III or IV
Time frame: 5 years
Health status evaluated by the Kansas City Cardiomyopathy Questionnaire
Time frame: 5 years
Health status evaluated by the SF-36 questionnaire
Time frame: 5 years
Six-minute walk test
Time frame: 5 years
Treatment Costs per quality adjusted life year Assessment of Safety
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthias Raschpichler contact
Michael Borger principal investigator
University Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transfemoral transcatheter valve-in-valve implantation and Surgical redo aortic valve replacement in people with Degenerative Aortic Valve Disease, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Borger (03418650, Michael.Borger@helios-gesundheit.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.