Clinical trial NCT05925335: The China Mviv Registry
Official title: Evaluation of Clinical Outcomes of Transseptal Transcatheter Mitral Valve-in-Valve Replacement for Degenerated Bioprostheses - The China Mviv Registry
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bioprosthesis Failure
Mitral Stenosis With Insufficiency
Mitral Stenosis
Mitral Regurgitation
Heart Failure
Lead sponsor: Xiamen Cardiovascular Hospital, Xiamen University
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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..

Detailed description: Due to a massive shift from mechanical to bioprosthetic valves with finite longevity, increasing numbers of patients are presenting with bioprosthetic mitral valve degeneration. Mitral valve reoperation, the standard therapy for the bioprosthetic failure in the past, often entails high risk due to age, multiple comorbidities et al. TMVR is an emerging treatment for the patients with bioprosthetic failure at high risk for conventional mitral valve surgery. Recent studies from US and Europe have demonstrated the safety and efficacy of TMVR in this population. However, there are limited data regarding clinical outcomes after TMVR from Asia-Pacific region. To evaluate the safety and efficacy of TMVR using balloon-expandable valve among those patients with high risk for redo surgery and those who refuse redo surgery after shared decision making even they have less than high risk.

Eligibility 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

Primary outcomes:
measure: all-cause mortality
timeFrame: 12 months
measure: Rate of New hospitalization for heart failure
timeFrame: 12 months
Secondary outcomes:
measure: Technical success
timeFrame: 24 hours
measure: Procedure success
timeFrame: 12 months
measure: all-cause mortality
timeFrame: annual for five years
measure: Rate of New hospitalization for heart failure
timeFrame: annual for five years
measure: Rate of myocardial infarction
timeFrame: annual for five years
measure: Rate of neurological events
timeFrame: annual for five years
measure: Rate of Structural Valve dysfunction
timeFrame: annual for five years
measure: Clinical Benefit Endpoint
timeFrame: 30 days, 6 months, 12 months, annual for five years]
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Yan Wang
state: Fujian
Study officials:
affiliation: Clinical Trial Center of Xiamen Cardiovascular Hospital
name: Yan Wang, Dr
role: PRINCIPAL_INVESTIGATOR
References: