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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05784337
Other study ID # Mi-thos-FIM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 21, 2021
Est. completion date January 10, 2023

Study information

Verified date March 2023
Source Shanghai NewMed Medical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The Mi-thos® study is a single-arm, prospective, safety and performance clinical study.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date January 10, 2023
Est. primary completion date January 10, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Mi-thos® Transcatheter Mitral Valve Replacement System
Transcatheter Mitral Valve Replacement

Locations

Country Name City State
China Zhongshan Hospital, Fudan University Shanghai Shanghai
China First Affiliated Hospital of Air Force Medical University Xi'an Shanxi

Sponsors (1)

Lead Sponsor Collaborator
Shanghai NewMed Medical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
immediate post-surgical
Secondary Rate of all-cause mortality All-cause mortality after TMVR 30 days
Secondary Rate of Severe adverse event Severe adverse events rate after TMVR 30 days
Secondary 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)
30 days
Secondary 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
30 days
Secondary Incidence of arrhythmia or conduction block Incidence of arrhythmia or conduction block after TMVR 30 days
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