NCT04195984
Recruiting
Not Applicable
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.
ConditionsMitral Valve Regurgitation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Valve Regurgitation
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
- Enrollment
- 122
- Locations
- 3
- Primary Endpoint
- Freedom from all-cause mortality
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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;
Outcomes
Primary Outcomes
Freedom from all-cause mortality
Time Frame: 1 year
All-cause mortality after TMVR
Secondary Outcomes
- Freedom from all-cause mortality(30 days, 6months, 2-5 years)
- Severe adverse event rate(30 days, 6months, 1 year, 2-5 years)
- Kansas City Cardiomyopathy score(30 days, 6months, 1 year, 2-5 years)
- NYHA Heart Function Rating(30 days, 6months, 1 year, 2-5 years)
Study Sites (3)
Loading locations...
Similar Trials
Completed
Not Applicable
Mi-thos® Transcatheter Mitral Valve Replacement(First-in-Man Study)Mitral Valve RegurgitationNCT05784337Shanghai NewMed Medical Co., Ltd.11
Not yet recruiting
Not Applicable
Munich Transcatheter Mitral Valve Safety and EffectivenessMitral RegurgitationMitral Valve DiseaseNCT05871983P+F Products + Features GmbH60
Active, not recruiting
Not Applicable
Caisson Transcatheter Mitral Valve Replacement (TMVR)Mitral RegurgitationMitral Valve DiseaseMitral Valve FailureMitral DiseaseValve Heart DiseaseValve Disease, HeartNCT03661398Caisson Interventional LLC75
Unknown
Not Applicable
MitralStitch Mitral Valve Repair System for Mitral RegurgitationMitral RegurgitationNCT04061837Xijing Hospital10
Completed
Not Applicable
Cephea Transseptal Mitral Valve System FIHMitral RegurgitationNCT03988946Cephea Valve Technologies1