Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation
NCT ID: NCT02471664
Last Updated: 2017-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2015-07-31
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single
Intervention: Device: Mitral Loop Cerclage Annuloplasty with CSTV Protective Device
Mitral Loop Cerclage Annuloplasty
Interventions
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Mitral Loop Cerclage Annuloplasty
Other Intervention Names
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Eligibility Criteria
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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
* 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
20 Years
85 Years
ALL
No
Sponsors
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Tau-MEDICAL Co., Ltd.
INDUSTRY
Responsible Party
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June-Hong Kim, MD, PhD
Professor
Principal Investigators
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June-Hong Kim, MD, Ph D
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Yangsan Hospital
Locations
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National Institues of Health
Bethesda, Maryland, United States
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Countries
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References
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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.
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.
Other Identifiers
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TPMMLC
Identifier Type: -
Identifier Source: org_study_id