Clinical trial NCT03453853: Atrial Functional Mitral Regurgitation Response In Mitral Loop Cerclage Annuloplasty (AFRICA 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Atrial Functional Mitral Regurgitation
Heart Failure
Keywords: Percutaneous mitral valve repair
Coronary sinus annuloplasty
Mitral loop cerclage
atrial fibrillation
Mitral Regurgitation
Lead sponsor: Tau-MEDICAL Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-05
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of mitral regurgitation severity(1)
timeFrame: 1 month
measure: Change of mitral regurgitation severity(2)
timeFrame: 1 month
measure: Change in mitral annulus geometry
timeFrame: 1 month
measure: Rate of adverse events as a measure of safety
timeFrame: 1 month
Secondary outcomes:
measure: Change of mitral regurgitation severity(1)
timeFrame: 6 months
measure: Change of mitral regurgitation severity(2)
timeFrame: 6 months
measure: Change in mitral annulus geometry
timeFrame: 6 months
measure: Change in left ventricle volumes
timeFrame: 6 months
measure: Electrical remodeling
timeFrame: 6 months
measure: Change in subjects' symptoms referred to NYHA Classification System
timeFrame: 6 months
measure: Technical success rate of the implantation
timeFrame: 6 months
measure: Rate of adverse events as a measure of safety
timeFrame: 6 months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
state: Dalseo-gu
city: Bucheon-si
country: Korea, Republic of
facility: Sejong HOSPITAL
state: Gyeonggi-do
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongsangnamdo
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital (CNU Hospital)
state: Jung-gu
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
state: Nam-gu
city: Ulsan
country: Korea, Republic of
facility: Ulsan Hospital
state: Nam-gu
city: Seoul
country: Korea, Republic of
facility: ASAN Medical Center
state: Songpa-gu
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Yong-Hyun Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.