The China Mviv Registry (NCT05925335) | Clinical Trial Compass
UnknownNot Applicable
The China Mviv Registry
China50 participantsStarted 2023-07-11
Plain-language summary
Mitral valve disease is the most common structure heart disease, and surgical valve replacement is an important treatment for severe mitral valve disease. There are 2 types of valve often been used, mechanical or biological protheses valves. Mechanical valve requires lifelong use of anticoagulants and take the risk of bleeding through all lifetime, but bioprotheses valve do not..
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
all-cause mortality
Timeframe: 12 months
2
Rate of New hospitalization for heart failure
Timeframe: 12 months
Trial details
NCT IDNCT05925335
SponsorXiamen Cardiovascular Hospital, Xiamen University