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.

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04195984

Enrollment

122

Registered

2019-12-12

Start date

2021-03-25

Completion date

2027-01-31

Last updated

2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Regurgitation

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.

Interventions

DEVICEMi-thos® valve and transapical delivery system

Transcatheter mitral valve replacement system

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Freedom from all-cause mortality	30 days, 6months, 2-5 years	All-cause mortality 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
Kansas City Cardiomyopathy score	30 days, 6months, 1 year, 2-5 years	Kansas City Cardiomyopathy score after TMVR

Countries

China

Contacts

Primary ContactWang chunyang, CRA

cywang@newmed.cn(86)-21-20788668

Backup ContactXie xuyang, c

xyxie@newmed.cn(86)-21-20788668

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026