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New treatment option for Degenerative Aortic Valve Disease
Official title REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)
ClinicalTrials.gov ID: NCT07462624
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Indication for repeat intervention for failed surgical aortic bioprosthesis due to structural valve deterioration (SVD; prosthesis stenosis and/or...
- 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
You likely can't join if
- 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...
- 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...
- Patients who choose to receive a mechanical AVR.
The study team makes the final eligibility decision.
Where it's taking place
- Leipzig, Saxony, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leipzig, Saxony, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.