Mi-thos® Transcatheter Mitral Valve Replacement(First-in-Man Study)

Mitral Valve Regurgitation Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05784337
• Other study ID #: Mi-thos-FIM
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

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