Mi-thos® Transcatheter Mitral Valve Replacement Study

Not Applicable

Recruiting

• Conditions: Mitral Valve Regurgitation
• Interventions: Device: Mi-thos® valve and transapical delivery system

• Registration Number: NCT04195984
• Lead Sponsor: Shanghai NewMed Medical Co., Ltd.

Brief Summary

To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.

Detailed Description

The Mi-thos® study is an multicenter, single-arm, prospective, safety and performance clinical study.

Study Timeline

• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Study Start: 2021-03-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2026-05
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Mi-thos® valve and transapical delivery system	Transcatheter mitral valve replacement with the Mi-thos® valve and transcatheter delivery system

Primary Outcome Measures

Name	Time	Method
Freedom from all-cause mortality	1 year	All-cause mortality after TMVR

Secondary Outcome Measures

Name	Time	Method
Freedom from all-cause mortality	30 days, 6months, 2-5 years	All-cause mortality after TMVR
Kansas City Cardiomyopathy score	30 days, 6months, 1 year, 2-5 years	Kansas City Cardiomyopathy score after TMVR
Severe adverse event rate	30 days, 6months, 1 year, 2-5 years	Severe adverse events rate after TMVR
NYHA Heart Function Rating	30 days, 6months, 1 year, 2-5 years	NYHA Heart Function Rating after TMVR

Trial Locations

Locations (3)

Xijing hospital; 🇨🇳 Xi'an, Shanxi, China

Fuwai hospital; 🇨🇳 Beijing, Beijing, China

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China