Registry for transcatheter mitral valve replacement in patients with failing bioprosthetic valves
Evaluation of Clinical Outcomes of Transcatheter Transfemoral Mitral Valve-in-Valve Implantation in Polish Population- Observational Multicenter Registry
This study is testing a new way to replace failing mitral heart valves using a less invasive method for patients who are at high risk for traditional surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Warsaw Academic / other |
| Locations | 7 sites (Bialystok and 6 other locations) |
| Trial ID | NCT05625607 on ClinicalTrials.gov |
What this trial studies
This registry focuses on patients with failing surgically implanted mitral bioprosthetic valves who are experiencing moderate to severe stenosis or insufficiency. It aims to evaluate the safety and effectiveness of transcatheter mitral valve-in-valve implantation as an alternative to traditional surgical reoperation. The study involves collaboration among several medical universities in Poland to gather data on this emerging treatment method, particularly in high-surgical-risk patients. By documenting outcomes, the registry seeks to enhance understanding of this procedure's impact on the Polish population.
Who should consider this trial
Good fit: Ideal candidates are patients with failing mitral bioprosthetic valves showing moderate stenosis and/or insufficiency who are deemed suitable for transcatheter mitral valve replacement.
Not a fit: Patients who are disqualified from transcatheter mitral valve replacement will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with failing mitral bioprosthetic valves, improving their quality of life.
How similar studies have performed: Other studies have shown promising results with transcatheter mitral valve replacement in high-risk patients, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Failing surgically implanted mitral bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency * Qualification for TMVR by decision of the local Heart Team * Patient provided written informed consent Exclusion Criteria: \- Disqualification from TMVR
Where this trial is running
Bialystok and 6 other locations
- Medical University of Białystok — Bialystok, Poland (Recruiting)
- Medical University of Gdańsk — Gdansk, Poland (Recruiting)
- Medical University of Silesia — Katowice, Poland (Recruiting)
- Medical University of Łódź — Lodz, Poland (Recruiting)
- Medical University of Opole — Opole, Poland (Recruiting)
- Medical University of Warsaw — Warsaw, Poland (Recruiting)
- Institute of Cardiology — Warsaw, Poland (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.