NCT05784337

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

2 active sites

Status
completed

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 Start

First participant enrolled

April 21, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

1.7 years

First QC Date

March 12, 2023

Last Update Submit

March 22, 2023

Conditions

Mitral Valve Regurgitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Rate of all-cause mortality

    30 days

  • Rate of Severe adverse event

    30 days

  • Device success

    30 days

  • Procedural success

    30 days

  • Incidence of arrhythmia or conduction block

    30 days

Study Arms (1)

Mi-thos® Transcatheter Mitral Valve Replacement System

EXPERIMENTAL

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

Device: Mi-thos® Transcatheter Mitral Valve Replacement System

Interventions

Mi-thos® Transcatheter Mitral Valve Replacement SystemDEVICE

Transcatheter Mitral Valve Replacement

Mi-thos® Transcatheter Mitral Valve Replacement System

Eligibility Criteria

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

You may qualify if:

  • 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.

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;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

First Affiliated Hospital of Air Force Medical University

Xi’an, Shanxi, 710032, China

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

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

March 12, 2023

First Posted

March 24, 2023

Study Start

April 21, 2021

Primary Completion

January 10, 2023

Study Completion

January 10, 2023

Last Updated

March 24, 2023

Record last verified: 2023-03

Locations

CN(2)