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Recruiting Not applicable

Mi-thos® Transcatheter Mitral Valve Replacement Study

NCT04195984 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2021-03-25
Last updated
2025-02-13

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

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
Fuwai hospital Beijing Beijing Municipality Recruiting
Zhongshan Hospital Shanghai Shanghai Municipality Recruiting
Xijing hospital Xi’an Shanxi Recruiting
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