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To evaluate safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single | Experimental | Intervention: Device: Mitral Loop Cerclage Annuloplasty with CSTV Protective Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitral Loop Cerclage Annuloplasty | Device |
|
|
| 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 |
| 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 | |
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Inclusion Criteria:
(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:
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| Name | Affiliation | Role |
|---|---|---|
| June-Hong Kim, MD, Ph D | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institues of Health | Bethesda | Maryland | 20892 | United States | ||
| Pusan National University Yangsan Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19660696 | Background | 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. | |
| 28335897 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 10, 2020 | |
| Reset | Mar 25, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 10, 2020 | Mar 25, 2020 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| Yangsan |
| Gyeongsangnam-do |
| 626-770 |
| South Korea |
| Result |
| 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. |