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Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation | Clinical Trials | Clareo Health

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Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation

The Study on Safety and Feasibility of Mitral Loop Cerclage(MLC) Annuloplasty Procedure With Investigational Medical Device (MLC-B-45-75-R and Other 11 Models) : Single-centre, Open Label, Single Arm, Feasibility Test

NCT02471664•Tau-MEDICAL Co., Ltd.

View on ClinicalTrials.gov

Summary

To evaluate safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.

Detailed Description

The objective of this prospective, single-center, open label, feasibility test is to assess the safety and efficacy of Mitral Loop Cerclage Annuloplasty with CSTV protective device in treating functional mitral regurgitation (FMR) associated with heart failure.

Eligibility

Age

20 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•NYHA(New York Heart Association) Class III - IV, and symptomatic severe functional MR by 2014 ACC/AHA guideline in spite of optimal medical treatment.
•(For optimal medical treatments, ①ACE inhibitor or angiotensin receptor blocker ②β-blocker ③ aldosterone antagonists should be given for at least 3 months unless the subject has contraindication for each drug)

Exclusion Criteria

•Primary Mitral Regurgitation
•LV ejection fraction lower than 25%
•Creatinine ≥2.0 mg/dL
•Anomaly of Coronary Sinus
•Pre-existing devices in coronary sinus such as Implantable Cardioverter Defibrillator and Pacemaker
•2:1 Atriventricular AV block or higher AV block and ventricular tachycardia
•Subjects with functional MR who need CABG or AVR performed
•Subjects who have functional MR caused by aortic valve disease
•Subjects who have uncontrollable hyperthyroidism
•Subjects who have severe TR due to primary valve leaflet disease
+8 more criteria

Locations (2)

National Institues of Health

Bethesda, Maryland, United States

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Key Dates

Start Date

July 1, 2015

Primary Completion Date

March 1, 2016

Completion Date

July 1, 2016

Last Updated

October 13, 2017

Enrollment

ACTUAL participants

Conditions

Functional Mitral RegurgitationHeart Failure

Interventions

Mitral Loop Cerclage Annuloplasty

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 13, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation

Inclusion Criteria

Exclusion Criteria

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

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