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Completed

NCT Number: NCT05784337

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

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.

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Key information

Conditions

Mitral Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Hospital, Fudan University, Shanghai, Shanghai Municipality, China

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mi-thos® Transcatheter Mitral Valve Replacement System

Device

Transcatheter Mitral Valve Replacement

Primary outcomes

  1. Technical success

    Time frame: immediate post-surgical

    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 outcomes

  1. Rate of all-cause mortality

    Time frame: 30 days

    All-cause mortality after TMVR

  2. Rate of Severe adverse event

    Time frame: 30 days

    Severe adverse events rate after TMVR

  3. Device success

    Time frame: 30 days

    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)

  4. Procedural success

    Time frame: 30 days

    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

  5. Incidence of arrhythmia or conduction block

    Time frame: 30 days

    Incidence of arrhythmia or conduction block after TMVR

Sponsors and collaborators

Lead sponsor

Shanghai NewMed Medical Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2023
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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