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Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation

Primary Purpose

Functional Mitral Regurgitation, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Mitral Loop Cerclage Annuloplasty
Sponsored by
Tau Pnu Medical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Mitral Regurgitation focused on measuring Percutaneous mitral valve repair, Coronary sinus annuloplasty, Mitral loop cerclage

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Institues of Health
  • Pusan National University Yangsan Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single

Arm Description

Intervention: Device: Mitral Loop Cerclage Annuloplasty with CSTV Protective Device

Outcomes

Primary Outcome Measures

Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO)
Change in mitral annulus geometry (septal lateral dimension)
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

Secondary Outcome Measures

Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO)
Change in mitral annulus geometry (septal lateral dimension)
Change in mitral valve hemodynamics
Change in left ventricle volumes
Change in subjects' symptoms referred to NYHA (New York Heart Association) Classification System
Technical success rate of the implantation and technical feasibility
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

Full Information

First Posted
June 5, 2015
Last Updated
October 11, 2017
Sponsor
Tau Pnu Medical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02471664
Brief Title
Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tau Pnu Medical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Mitral Regurgitation, Heart Failure
Keywords
Percutaneous mitral valve repair, Coronary sinus annuloplasty, Mitral loop cerclage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single
Arm Type
Experimental
Arm Description
Intervention: Device: Mitral Loop Cerclage Annuloplasty with CSTV Protective Device
Intervention Type
Device
Intervention Name(s)
Mitral Loop Cerclage Annuloplasty
Other Intervention Name(s)
MLC series (MLC-B-45-75-R and other 11 models)
Primary Outcome Measure Information:
Title
Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO)
Time Frame
1 month
Title
Change in mitral annulus geometry (septal lateral dimension)
Time Frame
1 month
Title
Rate of adverse events as a measure of safety
Description
Rate of composite endpoint of MACE (Major Adverse Cardiac Event) * Death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Change of mitral regurgitation severity by regurgitant volume (RV) and effective regurgitant orifice (ERO)
Time Frame
6 months
Title
Change in mitral annulus geometry (septal lateral dimension)
Time Frame
6 months
Title
Change in mitral valve hemodynamics
Time Frame
6 months
Title
Change in left ventricle volumes
Time Frame
6 months
Title
Change in subjects' symptoms referred to NYHA (New York Heart Association) Classification System
Time Frame
6 months
Title
Technical success rate of the implantation and technical feasibility
Time Frame
6 months
Title
Rate of adverse events as a measure of safety
Description
Rate of composite endpoint of MACE (Major Adverse Cardiac Event) * Death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
June-Hong Kim, MD, Ph D
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institues of Health
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeongsangnamdo
ZIP/Postal Code
626-770
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
19660696
Citation
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.
Results Reference
background
PubMed Identifier
28335897
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):597-610. doi: 10.1016/j.jcin.2016.12.282.
Results Reference
result

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Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation

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