Mi-thos® Transcatheter Mitral Valve Replacement Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mi-thos® valve and transapical delivery system.
- Who it may be relevant to
- Registry conditions: Mitral Valve Regurgitation. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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
- Device Mi-thos® valve and transapical delivery system
Transcatheter mitral valve replacement system
Primary outcome measures
- Freedom from all-cause mortality [Time frame: 1 year]
Secondary outcome measures (4)
- Freedom from all-cause mortality [Time frame: 30 days, 6months, 2-5 years]
- Severe adverse event rate [Time frame: 30 days, 6months, 1 year, 2-5 years]
- NYHA Heart Function Rating [Time frame: 30 days, 6months, 1 year, 2-5 years]
- Kansas City Cardiomyopathy score [Time frame: 30 days, 6months, 1 year, 2-5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 3 centers
- Fuwai hospital — Beijing
- Zhongshan Hospital — Shanghai
- Xijing hospital — Xi’an
Identifiers
NCT: NCT04195984 · M-valve-2018-06