Clinical trial NCT03601039: Safety and Efficacy Study of Absnow Absorbable ASD Closure System For Treating ASD Patients
Official title: Evaluation of Safety and Efficacy of the Absnow Absorbable ASD Closure System For Treating ASD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Septal Defects, Atrial
Atrial Septal Defect
Keywords: Absnow Absorbable Occluder
ASD Occluder
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 144
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the safety and efficacy of Absnow absorbable ASD closure system for treating patients with atrial septal defect.

Detailed description: Atrial Septal Defect (hereinafter referred to as "ASD") is a common congenital heart disease (hereinafter referred to as "CHD"), accounting for about 10% of CHD in children.Initially，ASD was treated by surgical operation. Nowdays transcatheter ASD closure, characterized by minimal invasion, definite curative effect, short recovery period, and no need for cardiopulmonary bypass, provides a new safe and effective therapy for CHD. According to a large number of clinical reports, the use of transcatheter closure devices for ASD closure has a high success rate, good closure effect and low risk of complications.

Absnow absorbable ASD closure system has undergone implantation experiments that implant it into animal (pig) ASD models, with the implantation success rate being 100%. Up to 2 years' observation indicated that the cardiomyocytes and endothelial cells covering the implanted device were not different from those of the control group (nickel-titanium alloy occluder) and were of a great number, and the inflammatory response was remarkably lower than that of the control group. During the observation period, all occluders in the trial did not fall off or were displaced, no evident postoperative complications and therefore, this occluder has the feasibility of local application and system safety.

Absnow absorbable ASD closure system developed by LifeTech Scientific passed the registration inspection of CFDA Shenzhen Medical Device Quality Monitoring and Inspection Center, verifying that this closure system conforms to the product technical specification in mechanical strength, physiochemical properties and biological properties. According to the provisions in Measures for Administration of Medical Device Registration (No. 4 Order) and Regulation on Quality Management of Medical Device Clinical Trial (No. 25) issued by CFDA, this product has the conditions for clinical trial.

Eligibility criteria: Inclusion Criteria:

* Age ≥3 , weight ≥10Kg
* Secundum left-to-right shunt ASD with hemodynamic significance
* Distance from the defect edge to coronary vein sinus, superior and inferior vena cava, pulmonary vein≥5mm and AV valve should be ≥7mm
* The atrial septum length (stretched diameter) should be greater than the diameter of left disk

Exclusion Criteria:

* Patients of primum, venous sinus and coronary sinus ASD
* Patients with atrial septum defect ≥26mm
* Patients with other structural heart disease in addition to ASD
* Patients with complication of obstructive pulmonary arterial hypertension, Eisenmenger syndrome
* Infective endocarditis patients
* Patients with hemolysis or hemorrhagic disease, unhealed ulcer or any taboo about aspirin (except being able to take other anti-platelet agent for consecutive six months) within one month before implantation
* Patients with thrombosis(especially in left atrium or left atrial appendage thrombus) as shown by echocardiography
* Patients with known condition of hypercoagulation status
* Patients ever received heart operation
* Patients allergic to PLLA
* Patients refusing to sign the informed consent form
* Patients with poor compliance on treatment and poor cooperation on follow-up visits
* Patients that are in pregnancy or lactation, or planned for pregnancy or get a positive pregnancy test result during the screening period
* Patients that have participated in any clinical trial that may affect the evaluation of the device in this trial and not completed or withdrawn from the previous clinical trial within 3 months prior to this trial screening period
* The patients considered to be not eligible for this clinical trial by the investigator

Primary outcomes:
measure: The successful rate at 30-day post ASD closure operative,which meaning that the TTE or TEE observation shows that residual shunt <5mm at 30-days postoperative.
timeFrame: 30-day post ASD closure operative
measure: The rate of severe complication during 360-day post ASD closure operative
timeFrame: 360-day post ASD closure operative
Secondary outcomes:
measure: immediate operation success rates
timeFrame: immediate postoperative
measure: Device-related AE (adverse event) rates
timeFrame: 5 years post operation
measure: Device-related SAE (serious adverse event) rates
timeFrame: 5 years post operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Pan Xiangbin
state: Beijing
city: Chongqing
country: China
facility: Yi Kaijian
state: Chongqing
city: Guangzhou
country: China
facility: Zhang Zhiwei
state: Guangdong
city: Harbin
country: China
facility: Yu Bo
state: Heilongjiang
city: Zhenzhou
country: China
facility: Fan Taibing
state: Henan
city: Changsha
country: China
facility: Fang Zhenfei
state: Hunan
city: Nanjing
country: China
facility: Kong Xiangqing
state: Jiangsu
city: Shanghai
country: China
facility: Chen Sun
state: Shanghai
city: Shanghai
country: China
facility: Li Fei
state: Shanghai
city: Shenzhen
country: China
facility: Liu Cong
state: Shenzhen
city: Hangzhou
country: China
facility: Gong Fangqi
state: Zhejiang
Study officials:
References:
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citation: Leenslag JW, Pennings AJ, Bos RR, Rozema FR, Boering G. Resorbable materials of poly(L-lactide). VII. In vivo and in vitro degradation. Biomaterials. 1987 Jul;8(4):311-4. doi: 10.1016/0142-9612(87)90121-9.