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Recruiting NCT07462624

REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)

No phase Interventional Degenerative Aortic Valve Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transfemoral transcatheter valve-in-valve implantation, Surgical redo aortic valve replacement.
Who it may be relevant to
Registry conditions: Degenerative Aortic Valve Disease. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Herzzentrum Leipzig GmbH — Leipzig

Identifiers

NCT: NCT07462624 · 2024-0081

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗