Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation
- Conditions
- Functional Mitral RegurgitationHeart Failure
- Interventions
- Device: Mitral Loop Cerclage Annuloplasty
- Registration Number
- NCT02471664
- Lead Sponsor
- Tau Pnu Medical Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Mitral Loop Cerclage Annuloplasty Intervention: Device: Mitral Loop Cerclage Annuloplasty with CSTV Protective Device
- Primary Outcome Measures
Name Time Method Rate of adverse events as a measure of safety 1 month Rate of composite endpoint of MACE (Major Adverse Cardiac Event)
\* Death, myocardial infarction, cardiac tamponade, device related cardiac surgery, strokeChange 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
- Secondary Outcome Measures
Name Time Method Technical success rate of the implantation and technical feasibility 6 months 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 Rate of adverse events as a measure of safety 6 months Rate of composite endpoint of MACE (Major Adverse Cardiac Event)
\* Death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke
Trial Locations
- Locations (2)
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Gyeongsangnamdo, Korea, Republic of
National Institues of Health
🇺🇸Bethesda, Maryland, United States