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
Verified date | October 2017 |
Source | Tau Pnu Medical Co.,Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Pusan National University Yangsan Hospital | Yangsan | Gyeongsangnamdo |
United States | National Institues of Health | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
Tau Pnu Medical Co.,Ltd. |
United States, Korea, Republic of,
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
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 |
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