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Trial record 1 of 1 for:    NCT02471664
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Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471664
Recruitment Status : Completed
First Posted : June 15, 2015
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
June-Hong Kim, MD, PhD, Pusan National University Yangsan Hospital

Brief Summary:
To evaluate safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.

Condition or disease Intervention/treatment Phase
Functional Mitral Regurgitation Heart Failure Device: Mitral Loop Cerclage Annuloplasty Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : July 2016

Arm Intervention/treatment
Experimental: Single
Intervention: Device: Mitral Loop Cerclage Annuloplasty with CSTV Protective Device
Device: Mitral Loop Cerclage Annuloplasty
Other Name: MLC series (MLC-B-45-75-R and other 11 models)




Primary Outcome Measures :
  1. Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO) [ Time Frame: 1 month ]
  2. Change in mitral annulus geometry (septal lateral dimension) [ Time Frame: 1 month ]
  3. Rate of adverse events as a measure of safety [ Time Frame: 1 month ]

    Rate of composite endpoint of MACE (Major Adverse Cardiac Event)

    * Death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke



Secondary Outcome Measures :
  1. Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO) [ Time Frame: 6 months ]
  2. Change in mitral annulus geometry (septal lateral dimension) [ Time Frame: 6 months ]
  3. Change in mitral valve hemodynamics [ Time Frame: 6 months ]
  4. Change in left ventricle volumes [ Time Frame: 6 months ]
  5. Change in subjects' symptoms referred to NYHA (New York Heart Association) Classification System [ Time Frame: 6 months ]
  6. Technical success rate of the implantation and technical feasibility [ Time Frame: 6 months ]
  7. Rate of adverse events as a measure of safety [ Time Frame: 6 months ]

    Rate of composite endpoint of MACE (Major Adverse Cardiac Event)

    * Death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke




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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471664


Locations
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United States, Maryland
National Institues of Health
Bethesda, Maryland, United States, 20892
Korea, Republic of
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnamdo, Korea, Republic of, 626-770
Sponsors and Collaborators
Tau Pnu Medical Co., Ltd.
Investigators
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Principal Investigator: June-Hong Kim, MD, Ph D Pusan National University Yangsan Hospital
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: June-Hong Kim, MD, PhD, Professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT02471664    
Other Study ID Numbers: TPMMLC
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Keywords provided by June-Hong Kim, MD, PhD, Pusan National University Yangsan Hospital:
Percutaneous mitral valve repair
Coronary sinus annuloplasty
Mitral loop cerclage
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases