Mi-thos® Transcatheter Mitral Valve Replacement Study

Evaluation of the Efficacy and Safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in Patients with Severe Mitral Valve Disease At High Surgical Risk.

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

Study Overview

• Status: Recruiting
• Conditions: Mitral Valve Regurgitation
• Intervention / Treatment: Device: Mi-thos® valve and transapical delivery system

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wang chunyang, CRA; Phone Number: (86)-21-20788668; Email: cywang@newmed.cn
• Study Contact Backup: Name: Xie xuyang, c; Phone Number: (86)-21-20788668; Email: xyxie@newmed.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Fuwai Hospital
      • Contact: Zheng zhe, Chief; Phone Number: (+86)010-88396051; Email: zhengzhe@fuwai.com
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital
      • Contact: Wang chunsheng, Chief; Phone Number: 2512 (86)021-64041990; Email: cswang@medmail.com.cn
  • Shanxi
    • Xi'an, Shanxi, China, 710032
      • Recruiting
      • Xijing Hospital
      • Contact: Yang jian, Chief; Phone Number: (+86)029-84774114; Email: yangjian@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Transcatheter mitral valve replacement with the Mi-thos® valve and transcatheter delivery system	Device: Mi-thos® valve and transapical delivery system; Transcatheter mitral valve replacement system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from all-cause mortality	All-cause mortality after TMVR	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai NewMed Medical Co., Ltd.
• Investigators: Principal Investigator: Wang chunsheng, Chief, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2021
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: M-valve-2018-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No