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

NCT03453853 | Completed Phase 1

• 1 other identifier: AFRICA
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Atrial Functional Mitral Regurgitation; Heart Failure

Keywords

Percutaneous mitral valve repair; Coronary sinus annuloplasty; Mitral loop cerclage; atrial fibrillation; Mitral Regurgitation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Change of mitral regurgitation severity(1)

  6 months

• Change of mitral regurgitation severity(2)

  6 months

• Change in mitral annulus geometry

  6 months

• Change in left ventricle volumes

  6 months

• Electrical remodeling

  6 months

Study Arms (1)

Mitral Loop Cerclage

EXPERIMENTAL

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

Device: Mitral Loop Cerclage Annuloplasty

Interventions

Mitral Loop Cerclage Annuloplasty DEVICE

Atrial Functional mitral regurgitation Response In mitral loop Cerclage Annuloplasty

Also known as: (MLC-B-45-75-R and other 11 models)

Mitral Loop Cerclage

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• :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

Sponsors & Collaborators

• Tau-MEDICAL Co., Ltd.: lead

Study Sites (7)

Keimyung University Dongsan Hospital

Daegu, Dalseo-gu, 42601, South Korea

Location

Sejong HOSPITAL

Bucheon-si, Gyeonggi-do, 14754, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50602, South Korea

Location

Chungnam National University Hospital (CNU Hospital)

Daejeon, Jung-gu, 35015, South Korea

Location

Yeungnam University Hospital

Daegu, Nam-gu, 42415, South Korea

Location

Ulsan Hospital

Ulsan, Nam-gu, 44686, South Korea

Location

ASAN Medical Center

Seoul, Songpa-gu, 05505, South Korea

Location

Related 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.

  PMID: 19660696 BACKGROUND

• 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.

  PMID: 28335897 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Valve Diseases

Study Officials

• Yong-Hyun Park, MD, PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: March 5, 2018
• Study Start: April 2, 2018
• Primary Completion: November 17, 2018
• Study Completion: April 3, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-04

Locations

KR (7)