Back to resultsMi-thos® Transcatheter Mitral Valve Replacement(First-in-Man Study)
Primary Purpose
Mitral Valve Regurgitation
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mi-thos® Transcatheter Mitral Valve Replacement System
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Valve Regurgitation
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; 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; Life expectancy < 12 months; Patients with severe thoracic deformities.
Sites / Locations
- Zhongshan Hospital, Fudan University
- First Affiliated Hospital of Air Force Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mi-thos® Transcatheter Mitral Valve Replacement System
Arm Description
Transcatheter mitral valve replacement with the Mi-thos® valve and transcatheter delivery system
Outcomes
Primary Outcome Measures
Technical success
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 Outcome Measures
Rate of all-cause mortality
All-cause mortality after TMVR
Rate of Severe adverse event
Severe adverse events rate after TMVR
Device success
All of the following must be present:
I. Absence of procedural mortality or stroke; and II. Proper placement and positioning of the device; and III. Freedom from unplanned surgical or interventional procedures related to the device or access procedure; and
IV. Continued intended safety and performance of the device, including:
A. No evidence of structural or functional failure B. No specific device-related technical failure issues and complications C. Significant alterations in mitral valve hemodynamics (MR≤moderate/EOA≥ 1.5 cm2/mean transmitral gradient < 5 mmHg/no paravalvular MR associated hemolysis)
Procedural success
All of the following must be present:
I. Device success, and
II. Absence of major device or procedure related serious adverse events, including:
A. Death B. Stroke C. Life-threatening bleeding (MVARC scale) D. Major vascular complications E. Major cardiac structural complications F. Stage 2 or 3 acute kidney injury (includes new dialysis) G. Myocardial infarction or coronary ischaemia requiring PCI or CABG H. Severe hypotension, heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments I. Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
Incidence of arrhythmia or conduction block
Incidence of arrhythmia or conduction block after TMVR
Full Information
NCT ID
NCT05784337
First Posted
March 12, 2023
Last Updated
March 22, 2023
Sponsor
Shanghai NewMed Medical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05784337
Brief Title
Mi-thos® Transcatheter Mitral Valve Replacement(First-in-Man 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(First-in-Man Study)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
January 10, 2023 (Actual)
Study Completion Date
January 10, 2023 (Actual)
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 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.
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
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mi-thos® Transcatheter Mitral Valve Replacement System
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® Transcatheter Mitral Valve Replacement System
Intervention Description
Transcatheter Mitral Valve Replacement
Primary Outcome Measure Information:
Title
Technical success
Description
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
Time Frame
immediate post-surgical
Secondary Outcome Measure Information:
Title
Rate of all-cause mortality
Description
All-cause mortality after TMVR
Time Frame
30 days
Title
Rate of Severe adverse event
Description
Severe adverse events rate after TMVR
Time Frame
30 days
Title
Device success
Description
All of the following must be present:
I. Absence of procedural mortality or stroke; and II. Proper placement and positioning of the device; and III. Freedom from unplanned surgical or interventional procedures related to the device or access procedure; and
IV. Continued intended safety and performance of the device, including:
A. No evidence of structural or functional failure B. No specific device-related technical failure issues and complications C. Significant alterations in mitral valve hemodynamics (MR≤moderate/EOA≥ 1.5 cm2/mean transmitral gradient < 5 mmHg/no paravalvular MR associated hemolysis)
Time Frame
30 days
Title
Procedural success
Description
All of the following must be present:
I. Device success, and
II. Absence of major device or procedure related serious adverse events, including:
A. Death B. Stroke C. Life-threatening bleeding (MVARC scale) D. Major vascular complications E. Major cardiac structural complications F. Stage 2 or 3 acute kidney injury (includes new dialysis) G. Myocardial infarction or coronary ischaemia requiring PCI or CABG H. Severe hypotension, heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments I. Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
Time Frame
30 days
Title
Incidence of arrhythmia or conduction block
Description
Incidence of arrhythmia or conduction block after TMVR
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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;
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;
Life expectancy < 12 months;
Patients with severe thoracic deformities.
Facility Information:
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
First Affiliated Hospital of Air Force Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
Learn more about this trial
Mi-thos® Transcatheter Mitral Valve Replacement(First-in-Man Study)
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