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(First-in-Man Study)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Valve Regurgitation
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
- Enrollment
- 11
- Locations
- 2
- Primary Endpoint
- Technical success
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
To evaluate the effectiveness and safety of the Mi-thos® Transcatheter Mitral Valve Replacement System in the treatment of patients with moderate or greater mitral regurgitation who are at high risk for conventional surgery, or who are not candidates for conventional surgery.
Detailed Description
The Mi-thos® study is a single-arm, prospective, safety and performance clinical study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Severe mitral regurgitation ≥ 3+;
- •Patients with an STS score \>8 or who have been evaluated by a cardiothoracic surgeon as high risk for conventional surgery or who cannot tolerate conventional open-heart surgery;
- •Age ≥ 65 years old;
- •Life expectancy \> 12 months;
- •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;
Outcomes
Primary Outcomes
Technical success
Time Frame: immediate post-surgical
All of the following must be present: I. Absence of procedural mortality; and II. Successful access, delivery, and retrieval of the device delivery system; and III. Successful deployment and correct positioning of the first intended device; and IV. Freedom from emergency surgery or reintervention related to the device or access procedure
Secondary Outcomes
- Rate of all-cause mortality(30 days)
- Device success(30 days)
- Procedural success(30 days)
- Incidence of arrhythmia or conduction block(30 days)
- Rate of Severe adverse event(30 days)