Clinical trial NCT02471664: Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Mitral Regurgitation
Heart Failure
Keywords: Percutaneous mitral valve repair
Coronary sinus annuloplasty
Mitral loop cerclage
Lead sponsor: Tau-MEDICAL Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-06-15
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO)
timeFrame: 1 month
measure: Change in mitral annulus geometry (septal lateral dimension)
timeFrame: 1 month
measure: Rate of adverse events as a measure of safety
timeFrame: 1 month
Secondary outcomes:
measure: Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO)
timeFrame: 6 months
measure: Change in mitral annulus geometry (septal lateral dimension)
timeFrame: 6 months
measure: Change in mitral valve hemodynamics
timeFrame: 6 months
measure: Change in left ventricle volumes
timeFrame: 6 months
measure: Change in subjects' symptoms referred to NYHA (New York Heart Association) Classification System
timeFrame: 6 months
measure: Technical success rate of the implantation and technical feasibility
timeFrame: 6 months
measure: Rate of adverse events as a measure of safety
timeFrame: 6 months
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institues of Health
state: Maryland
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnamdo
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: June-Hong Kim, MD, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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):597-610. doi: 10.1016/j.jcin.2016.12.282.