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

Primary Purpose

Atrial Functional Mitral Regurgitation, Heart Failure

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Mitral Loop Cerclage Annuloplasty

About this trial

This is an interventional treatment trial for Atrial Functional Mitral Regurgitation focused on measuring Percutaneous mitral valve repair, Coronary sinus annuloplasty, Mitral loop cerclage, atrial fibrillation, Mitral Regurgitation

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Keimyung University Dongsan Hospital
Sejong HOSPITAL
Pusan National University Yangsan Hospital
Chungnam National University Hospital (CNU Hospital)
Yeungnam University Hospital
Ulsan Hospital
ASAN Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mitral Loop Cerclage

Arm Description

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

Outcomes

Primary Outcome Measures

Change of mitral regurgitation severity(1)

changing regurgitant volume (RV,mL) compared with baseline

Change of mitral regurgitation severity(2)

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

Change in mitral annulus geometry

septal lateral dimension(mm)

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

Secondary Outcome Measures

Change of mitral regurgitation severity(1)

changing regurgitant volume (RV,mL) compared with baseline

Change of mitral regurgitation severity(2)

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

Change in mitral annulus geometry

septal lateral dimension(mm)

Change in left ventricle volumes

Changing of End-diastolic phase LV volumes(mL)

Electrical remodeling

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

Change in subjects' symptoms referred to NYHA Classification System

NYHA (New York Heart Association)

Technical success rate of the implantation

Technical feasibility by the implantation success rate (%)

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

Full Information

NCT ID

NCT03453853

First Posted

February 12, 2018

Last Updated

April 22, 2021

Sponsor

Tau Pnu Medical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03453853

Brief Title

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

Acronym

AFRICA

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

April 2, 2018 (Actual)

Primary Completion Date

November 17, 2018 (Actual)

Study Completion Date

April 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tau Pnu Medical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Functional Mitral Regurgitation, Heart Failure

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mitral Loop Cerclage

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Mitral Loop Cerclage Annuloplasty

Other Intervention Name(s)

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

Intervention Description

Atrial Functional mitral regurgitation Response In mitral loop Cerclage Annuloplasty

Primary Outcome Measure Information:

Title

Change of mitral regurgitation severity(1)

Description

changing regurgitant volume (RV,mL) compared with baseline

Time Frame

1 month

Title

Change of mitral regurgitation severity(2)

Description

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

Time Frame

1 month

Title

Change in mitral annulus geometry

Description

septal lateral dimension(mm)

Time Frame

1 month

Title

Rate of adverse events as a measure of safety

Description

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 Outcome Measure Information:

Title

Change of mitral regurgitation severity(1)

Description

changing regurgitant volume (RV,mL) compared with baseline

Time Frame

6 months

Title

Change of mitral regurgitation severity(2)

Description

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

Time Frame

6 months

Title

Change in mitral annulus geometry

Description

septal lateral dimension(mm)

Time Frame

6 months

Title

Change in left ventricle volumes

Description

Changing of End-diastolic phase LV volumes(mL)

Time Frame

6 months

Title

Electrical remodeling

Description

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

Time Frame

6 months

Title

Change in subjects' symptoms referred to NYHA Classification System

Description

NYHA (New York Heart Association)

Time Frame

6 months

Title

Technical success rate of the implantation

Description

Technical feasibility by the implantation success rate (%)

Time Frame

6 months

Title

Rate of adverse events as a measure of safety

Description

Rate of composite endpoint of MACE (Major Adverse Cardiac Event) *death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yong-Hyun Park, MD, PhD

Organizational Affiliation

Pusan National University Yangsan Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Keimyung University Dongsan Hospital

City

Daegu

State/Province

Dalseo-gu

ZIP/Postal Code

42601

Country

Korea, Republic of

Facility Name

Sejong HOSPITAL

City

Bucheon-si

State/Province

Gyeonggi-do

ZIP/Postal Code

14754

Country

Korea, Republic of

Facility Name

Pusan National University Yangsan Hospital

City

Yangsan

State/Province

Gyeongsangnamdo

ZIP/Postal Code

50602

Country

Korea, Republic of

Facility Name

Chungnam National University Hospital (CNU Hospital)

City

Daejeon

State/Province

Jung-gu

ZIP/Postal Code

35015

Country

Korea, Republic of

Facility Name

Yeungnam University Hospital

City

Daegu

State/Province

Nam-gu

ZIP/Postal Code

42415

Country

Korea, Republic of

Facility Name

Ulsan Hospital

City

Ulsan

State/Province

Nam-gu

ZIP/Postal Code

44686

Country

Korea, Republic of

Facility Name

ASAN Medical Center

City

Seoul

State/Province

Songpa-gu

ZIP/Postal Code

05505

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

19660696

Citation

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.

Results Reference

background

PubMed Identifier

28335897

Citation

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.

Results Reference

background

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

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