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

NCT ID: NCT03453853

Last Updated: 2021-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-02
• Study Completion Date: 2021-04-03

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.

Conditions

Atrial Functional Mitral Regurgitation; Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mitral Loop Cerclage

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

Group Type: EXPERIMENTAL

Mitral Loop Cerclage Annuloplasty

Intervention Type: DEVICE

Atrial Functional mitral regurgitation Response In mitral loop Cerclage Annuloplasty

Interventions

Mitral Loop Cerclage Annuloplasty

Atrial Functional mitral regurgitation Response In mitral loop Cerclage Annuloplasty

Intervention Type: DEVICE

Other Intervention Names

(MLC-B-45-75-R and other 11 models)

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tau-MEDICAL Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Yong-Hyun Park,MD,PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yong-Hyun Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

Locations

Keimyung University Dongsan Hospital

Daegu, Dalseo-gu, South Korea

Sejong HOSPITAL

Bucheon-si, Gyeonggi-do, South Korea

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Chungnam National University Hospital (CNU Hospital)

Daejeon, Jung-gu, South Korea

Yeungnam University Hospital

Daegu, Nam-gu, South Korea

Ulsan Hospital

Ulsan, Nam-gu, South Korea

ASAN Medical Center

Seoul, Songpa-gu, South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 19660696 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28335897 (View on PubMed)

Other Identifiers

AFRICA

Identifier Type: -

Identifier Source: org_study_id