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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; Functional Mitral Regurgitation
• Intervention / Treatment: Device: Mitral Loop Cerclage Annuloplasty

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeongsangnamdo
    • Yangsan, Gyeongsangnamdo, Korea, Republic of, 626-770
      • Pusan National University Yangsan Hospital
• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institues of Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• 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
• Subjects who have thrombosis and embolism
• Subjects who are pregnant, or lactating, or plan pregnancy during the clinical trials
• Subjects who are deemed not to be eligible in this study by physician's discretion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single; Intervention: Device: Mitral Loop Cerclage Annuloplasty with CSTV Protective Device	Device: Mitral Loop Cerclage Annuloplasty; Other Names: MLC series (MLC-B-45-75-R and other 11 models)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Technical success rate of the implantation and technical feasibility		6 months
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	6 months

Collaborators and Investigators

• Sponsor: Tau Pnu Medical Co., Ltd.
• Investigators: Principal Investigator: June-Hong Kim, MD, Ph D, Pusan National University Yangsan Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: June 5, 2015
• First Submitted That Met QC Criteria: June 10, 2015
• First Posted (Estimate): June 15, 2015

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Percutaneous mitral valve repair; Coronary sinus annuloplasty; Mitral loop cerclage
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: TPMMLC