Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation

Tau-Medical

Status: Completed

Conditions: Functional Mitral Regurgitation; Heart Failure

Treatments: Device: Mitral Loop Cerclage Annuloplasty

Study type: Interventional

Funder types: Industry

Identifiers

NCT02471664

TPMMLC

Details and patient eligibility

About

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

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Single

Experimental group

Description:

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

Treatment:

Device: Mitral Loop Cerclage Annuloplasty