NCT04351984

Brief Summary

This study is to evaluate the efficacy and safety of Transcatheter Mitral Valvuloplasty for Severe Mitral Regurgitation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

April 16, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

October 20, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

1.2 years

First QC Date

April 16, 2020

Last Update Submit

February 14, 2022

Conditions

Mitral Valve InsufficiencyMitral RegurgitationMitral Valve Regurgitation

Keywords

MitraClip

Outcome Measures

Primary Outcomes (1)

  • Mitral regurgitation

    1 month

Secondary Outcomes (8)

  • All cause death

    1 year

  • Stroke

    1 year

  • Myocardial infarction

    1 year

  • Re-hospitalization

    1 year

  • Acute kidney dysfunction

    5 days

  • +3 more secondary outcomes

Study Arms (1)

Severe Mitral Regurgitation

Device: MitraClip

Interventions

MitraClipDEVICE

Transcatheter Mitral Valvuloplasty with MitraClip

Also known as: Transcatheter Mitral Valvuloplasty
Severe Mitral Regurgitation

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with severe mitral regurgitation

You may qualify if:

  • Significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus \[degenerative MR\] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.
  • Age 19 and more
  • Written informed consent

You may not qualify if:

  • Patients who cannot tolerate procedural anticoagulation or post-procedural antiplatelet regimen
  • Active endocarditis of the mitral valve
  • Rheumatic mitral valve disease
  • Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 17, 2020

Study Start

October 20, 2020

Primary Completion

December 16, 2021

Study Completion

December 31, 2021

Last Updated

February 24, 2022

Record last verified: 2022-02

Locations

KR(1)