Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy