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

Heart Failure Clinical Trial

— AFRICA  

Official title:

The Study for Atrial Functional Mitral Regurgitation Response In Mitral Loop Cerclage Annuloplasty (AFRICA Study): Multi-center, Open Label, Single Arm, Feasibility Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03453853
• Other study ID #: AFRICA
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2, 2018
• Est. completion date: April 3, 2021

Study information

• Verified date: April 2021
• Source: Tau Pnu Medical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: April 3, 2021
• Est. primary completion date: November 17, 2018
• 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, Functional Mitral Regurgitation 3+ (Moderate/Severe) or 4+ (Severe) 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)
• 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

Related Conditions & MeSH terms

• Atrial Functional Mitral Regurgitation
• Heart Failure
• Mitral Valve Insufficiency

Intervention

Device:
• Mitral Loop Cerclage Annuloplasty
Atrial Functional mitral regurgitation Response In mitral loop Cerclage Annuloplasty

Locations

Country	Name	City	State
Korea, Republic of	Sejong HOSPITAL	Bucheon-si	Gyeonggi-do
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu	Dalseo-gu
Korea, Republic of	Yeungnam University Hospital	Daegu	Nam-gu
Korea, Republic of	Chungnam National University Hospital (CNU Hospital)	Daejeon	Jung-gu
Korea, Republic of	ASAN Medical Center	Seoul	Songpa-gu
Korea, Republic of	Ulsan Hospital	Ulsan	Nam-gu
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnamdo

Sponsors (1)

Lead Sponsor	Collaborator
Tau Pnu Medical Co., Ltd.

Country where clinical trial is conducted

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):597-610. doi: 10.1016/j.jcin.2016.12.282. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of mitral regurgitation severity(1)	changing regurgitant volume (RV,mL) compared with baseline	1 month
Primary	Change of mitral regurgitation severity(2)	changing effective regurgitant orifice (ERO,cm^2) compared with baseline	1 month
Primary	Change in mitral annulus geometry	septal lateral dimension(mm)	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(1)	changing regurgitant volume (RV,mL) compared with baseline	6 months
Secondary	Change of mitral regurgitation severity(2)	changing effective regurgitant orifice (ERO,cm^2) compared with baseline	6 months
Secondary	Change in mitral annulus geometry	septal lateral dimension(mm)	6 months
Secondary	Change in left ventricle volumes	Changing of End-diastolic phase LV volumes(mL)	6 months
Secondary	Electrical remodeling	change in electrocardiography (conversion of atrial fibrillation to normal sinus rhythm)	6 months
Secondary	Change in subjects' symptoms referred to NYHA Classification System	NYHA (New York Heart Association)	6 months
Secondary	Technical success rate of the implantation	Technical feasibility by the implantation success rate (%)	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

External Links

•   Mitral cerclage annuloplasty, a novel transcatheter treatment for secondary mitral valve regurgitation: Initial results in swine
•   Mitral Loop Cerclage Annuloplasty for Secondary Mitral Regurgitation: First Human Results