Transcatheter Mitral Valvuloplasty Pilot Study | NCT04351984

Studies
Transcatheter Mitral Valvuloplasty Pilot Study

NCT04351984

Sponsor

Duk-Woo Park, MD

Status

Completed

Last Update Posted

Feb 24, 2022Actual

Enrollment

5Actual

Phase

Not provided

Conditions

Mitral Valve Insufficiency
Mitral Regurgitation
Mitral Valve Regurgitation

Interventions

MitraClip

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 20, 2020Actual

Primary Completion Date

Dec 16, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Apr 16, 2020

First Submission Date that Met QC Criteria

Apr 16, 2020

First Posted Date

Apr 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2022

Last Update Posted Date

Feb 24, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Duk-Woo Park, MD, Associate Professor, Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Asan Medical CenterSponsor-Investigator

Lead Sponsor

Duk-Woo Park, MDOTHER

Collaborators

Name	Class
CardioVascular Research Foundation, Korea	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Severe Mitral Regurgitation			Device: MitraClip

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MitraClip	Device	Transcatheter Mitral Valvuloplasty with MitraClip	Severe Mitral Regurgitation

Measure	Description	Time Frame
Mitral regurgitation		1 month

Measure	Description	Time Frame
All cause death		1 year
Stroke		1 year
Myocardial infarction

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with severe mitral regurgitation

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008944	Mitral Valve Insufficiency

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided