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

Shanghai NewMed Medical Co., Ltd.11 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mitral Valve Regurgitation

Interventions

Mi-thos® Transcatheter Mitral Valve Replacement SystemDEVICE

Transcatheter Mitral Valve Replacement

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (2)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

First Affiliated Hospital of Air Force Medical University

Xi’an, Shanxi, China

Outcomes

Primary Outcomes

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

Time frame: immediate post-surgical

Secondary Outcomes

Rate of all-cause mortality

All-cause mortality after TMVR

Time frame: 30 days

Rate of Severe adverse event

Severe adverse events rate after TMVR

Time frame: 30 days

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)

Time frame: 30 days

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

Data from ClinicalTrials.gov

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