NCT04195984

Brief Summary

To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Mar 2021Jan 2027

First Submitted

Initial submission to the registry

December 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 25, 2021

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

5.1 years

First QC Date

December 10, 2019

Last Update Submit

February 11, 2025

Conditions

Mitral Valve Regurgitation

Outcome Measures

Primary Outcomes (1)

  • Freedom from all-cause mortality

    All-cause mortality after TMVR

    1 year

Secondary Outcomes (4)

  • Freedom from all-cause mortality

    30 days, 6months, 2-5 years

  • Severe adverse event rate

    30 days, 6months, 1 year, 2-5 years

  • NYHA Heart Function Rating

    30 days, 6months, 1 year, 2-5 years

  • Kansas City Cardiomyopathy score

    30 days, 6months, 1 year, 2-5 years

Study Arms (1)

Treatment

EXPERIMENTAL

Transcatheter mitral valve replacement with the Mi-thos® valve and transcatheter delivery system

Device: Mi-thos® valve and transapical delivery system

Interventions

Mi-thos® valve and transapical delivery systemDEVICE

Transcatheter mitral valve replacement system

Treatment

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Severe mitral valve regurgitation ≥ 3+;
  • High surgical risk fot open mitral valve surgery;
  • Age ≥ 65 years old;
  • Life expectancy \> 12 months;
  • As assessed by multidisciplinary cardiac team, patients who are not eligible for surgery;
  • Patients sign an informed consent form.

You may not qualify if:

  • 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;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fuwai hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Xijing hospital

Xi’an, Shanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Wang chunsheng, Chief

    Shanghai Zhongshan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang chunyang, CRA

CONTACT

(86)-21-20788668cywang@newmed.cn

Xie xuyang, c

CONTACT

(86)-21-20788668xyxie@newmed.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2019

First Posted

December 12, 2019

Study Start

March 25, 2021

Primary Completion

May 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

February 13, 2025

Record last verified: 2025-02

Locations

CN(3)