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

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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; Atrial Functional Mitral Regurgitation
• Intervention / Treatment: Device: Mitral Loop Cerclage Annuloplasty

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Dalseo-gu
    • Daegu, Dalseo-gu, Korea, Republic of, 42601
      • Keimyung University Dongsan Hospital
  • Gyeonggi-do
    • Bucheon-si, Gyeonggi-do, Korea, Republic of, 14754
      • Sejong Hospital
  • Gyeongsangnamdo
    • Yangsan, Gyeongsangnamdo, Korea, Republic of, 50602
      • Pusan National University Yangsan Hospital
  • Jung-gu
    • Daejeon, Jung-gu, Korea, Republic of, 35015
      • Chungnam National University Hospital (CNU Hospital)
  • Nam-gu
    • Daegu, Nam-gu, Korea, Republic of, 42415
      • Yeungnam University Hospital
    • Ulsan, Nam-gu, Korea, Republic of, 44686
      • Ulsan Hospital
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 05505
      • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mitral Loop Cerclage; Intervention: Device: Mitral Loop Cerclage Annuloplasty with CSTV Protective Device	Device: Mitral Loop Cerclage Annuloplasty; Atrial Functional mitral regurgitation Response In mitral loop Cerclage Annuloplasty; Other Names: (MLC-B-45-75-R and other 11 models)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of mitral regurgitation severity(1)	changing regurgitant volume (RV,mL) compared with baseline	1 month
Change of mitral regurgitation severity(2)	changing effective regurgitant orifice (ERO,cm^2) compared with baseline	1 month
Change in mitral annulus geometry	septal lateral dimension(mm)	1 month
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tau Pnu Medical Co., Ltd.
• Investigators: Principal Investigator: Yong-Hyun Park, MD, PhD, Pusan National University Yangsan Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2018
• Primary Completion (Actual): November 17, 2018
• Study Completion (Actual): April 3, 2021

Study Registration Dates

• First Submitted: February 12, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: atrial fibrillation; Mitral Regurgitation; Percutaneous mitral valve repair; Coronary sinus annuloplasty; Mitral loop cerclage
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: AFRICA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No