Back to resultsMi-thos® Transcatheter Mitral Valve Replacement Study
Primary Purpose
Mitral Valve Regurgitation
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mi-thos® valve and transapical delivery system
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Valve Regurgitation
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.
Sites / Locations
- Fuwai hospital
- Zhongshan HospitalRecruiting
- Xijing hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Transcatheter mitral valve replacement with the Mi-thos® valve and transcatheter delivery system
Outcomes
Primary Outcome Measures
Freedom from all-cause mortality
All-cause mortality after TMVR
Secondary Outcome Measures
Freedom from all-cause mortality
All-cause mortality after TMVR
Severe adverse event rate
Severe adverse events rate after TMVR
NYHA Heart Function Rating
NYHA Heart Function Rating after TMVR
Kansas City Cardiomyopathy score
Kansas City Cardiomyopathy score after TMVR
Full Information
NCT ID
NCT04195984
First Posted
December 10, 2019
Last Updated
June 27, 2022
Sponsor
Shanghai NewMed Medical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04195984
Brief Title
Mi-thos® Transcatheter Mitral Valve Replacement Study
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai NewMed Medical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
122 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Transcatheter mitral valve replacement with the Mi-thos® valve and transcatheter delivery system
Intervention Type
Device
Intervention Name(s)
Mi-thos® valve and transapical delivery system
Intervention Description
Transcatheter mitral valve replacement system
Primary Outcome Measure Information:
Title
Freedom from all-cause mortality
Description
All-cause mortality after TMVR
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Freedom from all-cause mortality
Description
All-cause mortality after TMVR
Time Frame
30 days, 6months, 2-5 years
Title
Severe adverse event rate
Description
Severe adverse events rate after TMVR
Time Frame
30 days, 6months, 1 year, 2-5 years
Title
NYHA Heart Function Rating
Description
NYHA Heart Function Rating after TMVR
Time Frame
30 days, 6months, 1 year, 2-5 years
Title
Kansas City Cardiomyopathy score
Description
Kansas City Cardiomyopathy score after TMVR
Time Frame
30 days, 6months, 1 year, 2-5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang chunyang, CRA
Phone
(86)-21-20788668
Email
cywang@newmed.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xie xuyang, c
Phone
(86)-21-20788668
Email
xyxie@newmed.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang chunsheng, Chief
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuwai hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zheng zhe, Chief
Phone
(+86)010-88396051
Email
zhengzhe@fuwai.com
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang chunsheng, Chief
Phone
(86)021-64041990
Ext
2512
Email
cswang@medmail.com.cn
Facility Name
Xijing hospital
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang jian, Chief
Phone
(+86)029-84774114
Email
yangjian@fmmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Mi-thos® Transcatheter Mitral Valve Replacement Study
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