Registry for patients with bioprosthetic mitral valve failure
Evaluation of Clinical Outcomes of Transseptal Transcatheter Mitral Valve-in-Valve Replacement for Degenerated Bioprostheses - The China Mviv Registry
This study is testing a new heart procedure for patients with failing bioprosthetic mitral valves who can't have traditional surgery to see if it helps improve their symptoms and overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xiamen Cardiovascular Hospital, Xiamen University Academic / other |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT05925335 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of transseptal transcatheter mitral valve-in-valve replacement (TMVR) for patients experiencing bioprosthetic mitral valve degeneration. It focuses on individuals who are at high risk for conventional mitral valve surgery or who refuse redo surgery after shared decision-making. The study aims to gather data on clinical outcomes in the Asia-Pacific region, where limited information currently exists. Participants must have symptomatic mitral valve disease and meet specific eligibility criteria, including age and functional class.
Who should consider this trial
Good fit: Ideal candidates include adults with degenerated surgical mitral bioprostheses and moderate to severe mitral regurgitation or severe stenosis.
Not a fit: Patients who are not symptomatic from mitral valve disease or those who are not eligible for TMVR due to other health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with bioprosthetic mitral valve failure, potentially improving their quality of life.
How similar studies have performed: Previous studies in the US and Europe have shown success with similar TMVR approaches, indicating potential for positive outcomes in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject had a degenerated surgical mitral bioprosthesis with at least moderate to severe mitral regurgitation or severe stenosis with echocardiographically derived mitral valve area (MVA) of ≤1.5 cm2 * Subjiect is symptomatic from mitral valve disease, as demonstrated by reported NYHA Functional Class II or greater. * Subject is at least 18 years old. * Heart team (including cardiac surgeon) agree on eligibility including assessment that transeptal, transcatheter mitral valve replacement (TsMVR) and redo surgical mitral valve replacement (rSMVR) are appropriate. * The study patient or the study patient's legal representative informed of the nature of the study, agreed to its provisions and provided written informed consent as approved by the Institutional Review Board (IRB) center. * The study Subject agreed to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which was conducted as a phone/clinic follow-up. Exclusion Criteria: * Subject was operable with the assessment of experienced Heart Team * Subject had evidence of an acute MI, percutaneous intervention, or a peripheral intervention ≤30 days prior to Portico ViV index procedure. * Subject had uncontrolled blood dyscrasias defined as: leukopenia (WBC\<3,000 mm3), acute anemia (Hb \<9 g/dL), or thrombocytopenia (platelet count \<50,000 cells/mm³). * Subject was considered hemodynamically unstable at the time of the ViV procedure (requiring inotropic support or mechanical heart assistance) * Subject had severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \<20% as measured by resting echocardiogram. * Subject had imaging evidence of intracardiac mass, thrombus or vegetation. * Subject had an active peptic ulcer or has/had upper gastrointestinal (GI) bleeding ≤3 months prior to ViV index procedure. * Subject had a documented history of a cerebrovascular accident (CVA) or a transient ischemic attack (TIA) ≤6 months prior to index procedure. * Subject had active bacterial endocarditis or ongoing sepsis ≤ 6 months prior to the index procedure. * Subject was unable to tolerate antiplatelet or anticoagulant therapy
Where this trial is running
Xiamen, Fujian
- Yan Wang — Xiamen, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Yan Wang, Dr — Clinical Trial Center of Xiamen Cardiovascular Hospital
- Study coordinator: Xiang Chen, Dr
- Email: Seanchenx@126.com
- Phone: 18033997788
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.