Clinical Trials in China / NCT04195984
Recruiting
Not applicable
Mi-thos® Transcatheter Mitral Valve Replacement Study
NCT04195984 · tracked via the Priya Life Science China tracker
Condition(s) studied
Mitral Valve Regurgitation
Investigational drug(s) / intervention(s)
Mi-thos® valve and transapical delivery system
Mi-thos® valve and transapical delivery system: Transcatheter mitral valve replacement system
Study summary
To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.
Eligibility
Inclusion Criteria:
* Severe mitral valve regurgitation ≥ 3+;
* High surgical risk fot open mitral valve surgery;
* Age ≥ 65 years old;
* Life expectancy \> 12 months;
* As assessed by multidisciplinary cardiac team, patients who are not eligible for surgery;
* Patients sign an informed consent form.
Exclusion Criteria:
* Previous cardiac mitral valve surgery;
* Active infections requiring antibiotic therapy;
* Clinically significant untreated Coronary Artery Disease (CAD);
* Pulmonary hypertension (Pulmonary systolic pressure \> 70 mmHg);
* Patients with severe right heart failure;
* Left ventricular ejection fraction \<25%;
* Diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis;
* Dialysis patient;
* Patients with severe coagulopathy;
* Patients with contraindications to anticoagulant drugs;
* Patients with stroke or transient ischemic within 30 days;
* Echocardiography found any intracardiac mass, left ventricle or atrial thrombus;
* Patients who require surgery or interventional therapy for other valvular lesions;
* Patients with severe macrovascular disease requiring surgical treatment;
* Patients with more than 70% of carotid stenosis;
* To be allergic to contrast agents, nickel-titanium memory alloys or bovine-derived products;
* Patients with severe neurological disorders affecting cognitive ability;
* Patients with severe thoracic deformities.
Primary outcome measure(s)
- Freedom from all-cause mortality — 1 year
All-cause mortality after TMVR
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Fuwai hospital | Beijing | Beijing Municipality | Recruiting |
| Zhongshan Hospital | Shanghai | Shanghai Municipality | Recruiting |
| Xijing hospital | Xi’an | Shanxi | Recruiting |
More Shanghai NewMed Medical Co., Ltd. trials in China
PrizValve® Transcatheter Aortic Valve Replacement Study
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04195984 on ClinicalTrials.gov ↗ ← All trials in China