Atrial Functional Mitral Regurgitation Response In Mitral Loop Cerclage Annuloplasty (AFRICA Study)
- Conditions
- Atrial Functional Mitral RegurgitationHeart Failure
- Interventions
- Device: Mitral Loop Cerclage Annuloplasty
- Registration Number
- NCT03453853
- Lead Sponsor
- Tau Pnu Medical Co., Ltd.
- Brief Summary
To evaluate second stage 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 and Atrial Fibrillation mitral regurgitation Response in Mitral Loop Cerclage annuloplasty.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mitral Loop Cerclage Mitral Loop Cerclage Annuloplasty Intervention: Device: Mitral Loop Cerclage Annuloplasty with CSTV Protective Device
- Primary Outcome Measures
Name Time Method Change of mitral regurgitation severity(1) 1 month changing regurgitant volume (RV,mL) compared with baseline
Change of mitral regurgitation severity(2) 1 month changing effective regurgitant orifice (ERO,cm\^2) compared with baseline
Change in mitral annulus geometry 1 month septal lateral dimension(mm)
Rate of adverse events as a measure of safety 1 month Rate of composite endpoint of MACE (Major Adverse Cardiac Event) \*death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke
- Secondary Outcome Measures
Name Time Method Change of mitral regurgitation severity(1) 6 months changing regurgitant volume (RV,mL) compared with baseline
Change of mitral regurgitation severity(2) 6 months changing effective regurgitant orifice (ERO,cm\^2) compared with baseline
Change in mitral annulus geometry 6 months septal lateral dimension(mm)
Change in left ventricle volumes 6 months Changing of End-diastolic phase LV volumes(mL)
Electrical remodeling 6 months change in electrocardiography (conversion of atrial fibrillation to normal sinus rhythm)
Change in subjects' symptoms referred to NYHA Classification System 6 months NYHA (New York Heart Association)
Technical success rate of the implantation 6 months Technical feasibility by the implantation success rate (%)
Rate of adverse events as a measure of safety 6 months Rate of composite endpoint of MACE (Major Adverse Cardiac Event) \*death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke
Trial Locations
- Locations (7)
Keimyung University Dongsan Hospital
🇰🇷Daegu, Dalseo-gu, Korea, Republic of
Sejong HOSPITAL
🇰🇷Bucheon-si, Gyeonggi-do, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Gyeongsangnamdo, Korea, Republic of
Chungnam National University Hospital (CNU Hospital)
🇰🇷Daejeon, Jung-gu, Korea, Republic of
Yeungnam University Hospital
🇰🇷Daegu, Nam-gu, Korea, Republic of
Ulsan Hospital
🇰🇷Ulsan, Nam-gu, Korea, Republic of
ASAN Medical Center
🇰🇷Seoul, Songpa-gu, Korea, Republic of