Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
122 participants
INTERVENTIONAL
2021-03-25
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Transcatheter mitral valve replacement with the Mi-thos® valve and transcatheter delivery system
Mi-thos® valve and transapical delivery system
Transcatheter mitral valve replacement system
Interventions
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Mi-thos® valve and transapical delivery system
Transcatheter mitral valve replacement system
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
65 Years
ALL
No
Sponsors
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Shanghai NewMed Medical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Wang chunsheng, Chief
Role: PRINCIPAL_INVESTIGATOR
Shanghai Zhongshan Hospital
Locations
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Fuwai hospital
Beijing, Beijing Municipality, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Xijing hospital
Xi’an, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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M-valve-2018-06
Identifier Type: -
Identifier Source: org_study_id
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