NCT02471664

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
2 countries

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

First Submitted

Initial submission to the registry

June 5, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

8 months

First QC Date

June 5, 2015

Last Update Submit

October 11, 2017

Conditions

Functional Mitral RegurgitationHeart Failure

Keywords

Percutaneous mitral valve repairCoronary sinus annuloplastyMitral loop cerclage

Outcome Measures

Primary Outcomes (3)

  • Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO)

    1 month

  • Change in mitral annulus geometry (septal lateral dimension)

    1 month

  • Rate of adverse events as a measure of safety

    Rate of composite endpoint of MACE (Major Adverse Cardiac Event) \* Death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke

    1 month

Secondary Outcomes (7)

  • Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO)

    6 months

  • Change in mitral annulus geometry (septal lateral dimension)

    6 months

  • Change in mitral valve hemodynamics

    6 months

  • Change in left ventricle volumes

    6 months

  • Change in subjects' symptoms referred to NYHA (New York Heart Association) Classification System

    6 months

  • +2 more secondary outcomes

Study Arms (1)

Single

EXPERIMENTAL

Intervention: Device: Mitral Loop Cerclage Annuloplasty with CSTV Protective Device

Device: Mitral Loop Cerclage Annuloplasty

Interventions

Mitral Loop Cerclage AnnuloplastyDEVICE
Also known as: MLC series (MLC-B-45-75-R and other 11 models)
Single

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • :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
  • Subjects who cannot be screened by cardiac CT
  • Subjects who have possibility of coronary artery pinching even with Mitral Loop Cerclage system judged by cardiac CT
  • Subjects who are unable to take anti-platelet agents
  • Subjects who are participated in other clinical trials within 1 month of enrollment
  • Subjects who have coagulation disorders
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Institues of Health

Bethesda, Maryland, 20892, United States

Location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 626-770, South Korea

Location

Related Publications (2)

  • Kim JH, Kocaturk O, Ozturk C, Faranesh AZ, Sonmez M, Sampath S, Saikus CE, Kim AH, Raman VK, Derbyshire JA, Schenke WH, Wright VJ, Berry C, McVeigh ER, Lederman RJ. Mitral cerclage annuloplasty, a novel transcatheter treatment for secondary mitral valve regurgitation: initial results in swine. J Am Coll Cardiol. 2009 Aug 11;54(7):638-51. doi: 10.1016/j.jacc.2009.03.071.

    PMID: 19660696BACKGROUND

  • Park YH, Chon MK, Lederman RJ, Sung SC, Je HG, Choo KS, Lee SH, Shin ES, Kim JS, Hwang KW, Lee SY, Chun KJ, Kim CM, Kim JH. Mitral Loop Cerclage Annuloplasty for Secondary Mitral Regurgitation: First Human Results. JACC Cardiovasc Interv. 2017 Mar 27;10(6):597-610. doi: 10.1016/j.jcin.2016.12.282.

    PMID: 28335897RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • June-Hong Kim, MD, Ph D

    Pusan National University Yangsan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 5, 2015

First Posted

June 15, 2015

Study Start

July 1, 2015

Primary Completion

March 1, 2016

Study Completion

July 1, 2016

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

US(1)KR(1)