Atrial Functional Mitral Regurgitation Response In Mitral Loop Cerclage Annuloplasty (AFRICA Study)

Tau-Medical

Status and phase

Completed

Phase 2

Phase 1

Conditions

Atrial Functional Mitral Regurgitation

Heart Failure

Treatments

Device: Mitral Loop Cerclage Annuloplasty

Study type

Interventional

Funder types

Industry

Identifiers

NCT03453853

AFRICA

Details and patient eligibility

About

To evaluate second stage 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 and Atrial Fibrillation mitral regurgitation Response in Mitral Loop Cerclage annuloplasty.

Enrollment

1 patient

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

NYHA(New York Heart Association) Class III - IV
and, Functional Mitral Regurgitation 3+ (Moderate/Severe) or 4+ (Severe) 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)

and, Chronic Atrial Fibrillation in electrocardiography (Persistent AF or Permanent AF)

Exclusion criteria

Primary Mitral Regurgitation
LV ejection fraction lower than 30%
Pulmonary arterial pressure ≥ 60mmHg
End-diastolic Left ventricular dimension ≥ 70mm
Subjects with functional MR who need CABG or AVR performed
Pre-existing stent in a coronary artery that is deemed to be in direct contact with the path of mitral loop cerclage along coronary sinus
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
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 primary MR
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 do not have septal vein or have unsuitable septal vein anatomy by cardiac CT or venogram
Subjects who have thrombosis and embolism
Creatinine ≥2.0 mg/dL
Subjects who have coagulation disorders
Subjects who are unable to take anti-platelet agents
Pre-existing devices such as Implantable Cardioverter Defibrillator and Pacemaker
Subjects who are pregnant, or lactating, or plan pregnancy during the clinical trials
Subjects who are participated in other clinical trials within 1 month of enrollment
Subjects who are deemed not to be eligible in this study by physician's discretion