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

April 22, 2021 updated by: Yong-Hyun Park,MD,PhD, Tau Pnu Medical Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of mitral regurgitation severity(1)
Time Frame: 1 month
changing regurgitant volume (RV,mL) compared with baseline
1 month
Change of mitral regurgitation severity(2)
Time Frame: 1 month
changing effective regurgitant orifice (ERO,cm^2) compared with baseline
1 month
Change in mitral annulus geometry
Time Frame: 1 month
septal lateral dimension(mm)
1 month
Rate of adverse events as a measure of safety
Time Frame: 1 month
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of mitral regurgitation severity(1)
Time Frame: 6 months
changing regurgitant volume (RV,mL) compared with baseline
6 months
Change of mitral regurgitation severity(2)
Time Frame: 6 months
changing effective regurgitant orifice (ERO,cm^2) compared with baseline
6 months
Change in mitral annulus geometry
Time Frame: 6 months
septal lateral dimension(mm)
6 months
Change in left ventricle volumes
Time Frame: 6 months
Changing of End-diastolic phase LV volumes(mL)
6 months
Electrical remodeling
Time Frame: 6 months
change in electrocardiography (conversion of atrial fibrillation to normal sinus rhythm)
6 months
Change in subjects' symptoms referred to NYHA Classification System
Time Frame: 6 months
NYHA (New York Heart Association)
6 months
Technical success rate of the implantation
Time Frame: 6 months
Technical feasibility by the implantation success rate (%)
6 months
Rate of adverse events as a measure of safety
Time Frame: 6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tau Pnu Medical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yong-Hyun Park, MD, PhD, Pusan National University Yangsan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 17, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 3, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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