Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02471664
• Other study ID #: TPMMLC
• Status: Completed
• Phase: N/A
• First received: June 5, 2015
• Last updated: October 11, 2017
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2017
• Source: Tau Pnu Medical Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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, ?ACE inhibitor or angiotensin receptor blocker ?ß-blocker ? 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

Related Conditions & MeSH terms

• Functional Mitral Regurgitation
• Heart Failure
• Mitral Valve Insufficiency

Intervention

Device:
• Mitral Loop Cerclage Annuloplasty

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnamdo
United States	National Institues of Health	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Tau Pnu Medical Co.,Ltd.

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

References & 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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO)		1 month
Primary	Change in mitral annulus geometry (septal lateral dimension)		1 month
Primary	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	Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO)		6 months
Secondary	Change in mitral annulus geometry (septal lateral dimension)		6 months
Secondary	Change in mitral valve hemodynamics		6 months
Secondary	Change in left ventricle volumes		6 months
Secondary	Change in subjects' symptoms referred to NYHA (New York Heart Association) Classification System		6 months
Secondary	Technical success rate of the implantation and technical feasibility		6 months
Secondary	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

External Links

•   Mitral cerclage annuloplasty, a novel transcatheter treatment for secondary mitral valve regurgitation: Initial results in swine
•   Mitral Loop Cerclage Annuloplasty for Secondary Mitral Regurgitation: First Human Results