Mi-thos® Transcatheter Mitral Valve Replacement Study

Mitral Valve Regurgitation Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04195984
• Other study ID #: M-valve-2018-06
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: January 2027

Study information

• Verified date: November 2023
• Source: Shanghai NewMed Medical Co., Ltd.
• Contact: Wang chunyang, CRA
• Phone: (86)-21-20788668
• Email: cywang[@]newmed.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: January 2027
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

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.

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• Mi-thos® valve and transapical delivery system
Transcatheter mitral valve replacement system

Locations

Country	Name	City	State
China	Fuwai hospital	Beijing	Beijing
China	Zhongshan Hospital	Shanghai	Shanghai
China	Xijing hospital	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai NewMed Medical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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