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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02471664
Other study ID # TPMMLC
Secondary ID
Status Completed
Phase N/A
First received June 5, 2015
Last updated October 11, 2017
Start date July 2015
Est. completion date July 2016

Study information

Verified date October 2017
Source Tau Pnu Medical Co.,Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
Mitral Loop Cerclage Annuloplasty


Locations

Country Name City State
Korea, Republic of Pusan National University Yangsan Hospital Yangsan Gyeongsangnamdo
United States National Institues of Health Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
Tau Pnu Medical Co.,Ltd.

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

References & Publications (2)

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

Outcome

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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