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CompletedNCT03453853AFRICAUpdated Apr 26, 2021

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

A Phase 1/2 interventional study of Mitral Loop Cerclage Annuloplasty in Atrial Functional Mitral Regurgitation and Heart Failure, sponsored by Tau-MEDICAL Co., Ltd.. Completed at 7 sites in Korea, Republic of. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-04-26.

Sponsored by Tau-MEDICAL Co., Ltd. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
20 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Atrial Functional Mitral Regurgitation
  • Heart Failure

Keywords

  • Percutaneous mitral valve repair
  • Coronary sinus annuloplasty
  • Mitral loop cerclage
  • atrial fibrillation
  • Mitral Regurgitation
03

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    Mitral Loop Cerclage

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

    Device: Mitral Loop Cerclage Annuloplasty

Interventions

  • DeviceMitral Loop Cerclage Annuloplasty

    Atrial Functional mitral regurgitation Response In mitral loop Cerclage Annuloplasty

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

05

What researchers measure

Primary outcomes

  1. Change of mitral regurgitation severity(1)

    changing regurgitant volume (RV,mL) compared with baseline

    Time frame: 1 month

  2. Change of mitral regurgitation severity(2)

    changing effective regurgitant orifice (ERO,cm\^2) compared with baseline

    Time frame: 1 month

  3. Change in mitral annulus geometry

    septal lateral dimension(mm)

    Time frame: 1 month

  4. 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

    Time frame: 1 month

Secondary outcomes

  1. Change of mitral regurgitation severity(1)

    changing regurgitant volume (RV,mL) compared with baseline

    Time frame: 6 months

  2. Change of mitral regurgitation severity(2)

    changing effective regurgitant orifice (ERO,cm\^2) compared with baseline

    Time frame: 6 months

  3. Change in mitral annulus geometry

    septal lateral dimension(mm)

    Time frame: 6 months

  4. Change in left ventricle volumes

    Changing of End-diastolic phase LV volumes(mL)

    Time frame: 6 months

  5. Electrical remodeling

    change in electrocardiography (conversion of atrial fibrillation to normal sinus rhythm)

    Time frame: 6 months

  6. Change in subjects' symptoms referred to NYHA Classification System

    NYHA (New York Heart Association)

    Time frame: 6 months

  7. Technical success rate of the implantation

    Technical feasibility by the implantation success rate (%)

    Time frame: 6 months

  8. 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

    Time frame: 6 months

06

Study locations

7 sites
  • Keimyung University Dongsan Hospital
    Daegu, Dalseo-gu 42601, Korea, Republic of
  • Sejong HOSPITAL
    Bucheon-si, Gyeonggi-do 14754, Korea, Republic of
  • Pusan National University Yangsan Hospital
    Yangsan, Gyeongsangnamdo 50602, Korea, Republic of
  • Chungnam National University Hospital (CNU Hospital)
    Daejeon, Jung-gu 35015, Korea, Republic of
  • Yeungnam University Hospital
    Daegu, Nam-gu 42415, Korea, Republic of
  • Ulsan Hospital
    Ulsan, Nam-gu 44686, Korea, Republic of
  • ASAN Medical Center
    Seoul, Songpa-gu 05505, Korea, Republic of
07

References and documents

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. PubMed 19660696 ↗
  • 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. PubMed 28335897 ↗
08

Registry details

Key details

Study ID
NCT03453853
Lead sponsor
Tau-MEDICAL Co., Ltd.
Responsible party
Yong-Hyun Park,MD,PhD (Professor, Pusan National University Yangsan Hospital) — Principal investigator
First posted
Mar 5, 2018
Start date
Apr 2, 2018
Primary completion
Nov 17, 2018
Completion
Apr 3, 2021
Last update
Apr 26, 2021

Study contacts

Yong-Hyun Park, MD, PhD
principal investigator · Pusan National University Yangsan Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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