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Atrial Functional Mitral RegurgitationPhase 1/2AFRICANCT03453853

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

A Phase 1/2 study testing Mitral Loop Cerclage Annuloplasty in people with Atrial Functional Mitral Regurgitation and Heart Failure, run by Tau-MEDICAL Co., Ltd. at 7 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 85 years
What is being tested?
Mitral Loop Cerclage Annuloplasty
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
7 sitesSouth Korea
Study dates
2 Apr 2018to 3 Apr 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 24Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

South Korea7 sites

  • Sejong HOSPITAL

    Bucheon-si, Gyeonggi-do, 14754

  • Keimyung University Dongsan Hospital

    Daegu, Dalseo-gu, 42601

  • Yeungnam University Hospital

    Daegu, Nam-gu, 42415

  • Chungnam National University Hospital (CNU Hospital)

    Daejeon, Jung-gu, 35015

  • ASAN Medical Center

    Seoul, Songpa-gu, 05505

  • Ulsan Hospital

    Ulsan, Nam-gu, 44686

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 50602

Other trials in South Korea

About this study

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

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.

Being tested
Mitral Loop Cerclage Annuloplasty
Keywords
Percutaneous mitral valve repair, Coronary sinus annuloplasty, Mitral loop cerclage, atrial fibrillation, Mitral Regurgitation
Medical subject headings
Heart Failure, Atrial Fibrillation, Mitral Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mitral Loop Cerclage AnnuloplastyDevice

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

    Atrial Functional mitral regurgitation Response In mitral loop Cerclage Annuloplasty

Study groups in NCT03453853
Study groupRoleWhat they receive
Mitral Loop CerclageExperimentalIntervention: Device: Mitral Loop Cerclage Annuloplasty with CSTV Protective Device
Receives: Device: Mitral Loop Cerclage Annuloplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of mitral regurgitation severity(1)

    changing regurgitant volume (RV,mL) compared with baseline

    Measured: 1 month

  2. Change of mitral regurgitation severity(2)

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

    Measured: 1 month

  3. Change in mitral annulus geometry

    septal lateral dimension(mm)

    Measured: 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

    Measured: 1 month

Secondary outcomes (8)

  1. Change of mitral regurgitation severity(1)

    changing regurgitant volume (RV,mL) compared with baseline

    Measured: 6 months

  2. Change of mitral regurgitation severity(2)

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

    Measured: 6 months

  3. Change in mitral annulus geometry

    septal lateral dimension(mm)

    Measured: 6 months

  4. Change in left ventricle volumes

    Changing of End-diastolic phase LV volumes(mL)

    Measured: 6 months

  5. Electrical remodeling

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

    Measured: 6 months

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

    NYHA (New York Heart Association)

    Measured: 6 months

  7. Technical success rate of the implantation

    Technical feasibility by the implantation success rate (%)

    Measured: 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2018
  2. Study start2 Apr 2018
  3. Primary completion17 Nov 2018
  4. Study completion3 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03453853
Sponsor's protocol ID
AFRICA
Acronym
AFRICA
Status last verified
Apr 2021
First submitted
12 Feb 2018
Last updated
26 Apr 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Mitral Loop Cerclage Annuloplasty in people with Atrial Functional Mitral Regurgitation and Heart Failure, run by Tau-MEDICAL Co., Ltd. at 7 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of mitral regurgitation severity(1) (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03453853, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.

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