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Safety and Efficacy Study of Absnow Absorbable ASD Closure System For Treating ASD Patients

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ClinicalTrials.gov Identifier: NCT03601039
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Lifetech Scientific (Shenzhen) Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Heart Septal Defects, Atrial Atrial Septal Defect Device: Absnow Absorbable ASD Closure System Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of the Absnow Absorbable ASD Closure System For Treating ASD Patients
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : June 30, 2024

Arm Intervention/treatment
Experimental: Absnow Absorbable ASD Closure System
All subjects are implanted with Absnow Absorbable ASD Occluder
Device: Absnow Absorbable ASD Closure System
the eligible subjects who meet the inclusion criteria should sign the ICF before operation (-30 to 0 day), then receive the Absnow absorbable ASD Closure System implantation. The follow-up time will be set as observation point : the next day after operation, 30-day post-operative , 90-day post-operative, 180-day post-operative, 360-day post-operative, 2 year post-operative, 3 year post-operative, 4 year post-operative and 5 year post-operative. If any AE/SAE occurs during clinical trial, the subjects should be observed till such AE/SAE disappear or stable.




Primary Outcome Measures :
  1. 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. [ Time Frame: 30-day post ASD closure operative ]
    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.

  2. The rate of severe complication during 360-day post ASD closure operative [ Time Frame: 360-day post ASD closure operative ]
    The rate of severe complication during 360-day post ASD closure operative. The severe complication includes all-cause mortality,coronary artery aeroembolism ,cardiac tamponade ,thromboembolism ,occluder dislodgment,repeated migraine, migraine,occluder displacement,mitral regurgitation,heart or aortic root perforation, high degree atrioventricular block and moderate to large residual shunt.


Secondary Outcome Measures :
  1. immediate operation success rates [ Time Frame: immediate postoperative ]
    the occluder is successfully implanted which means left and right disks are effectively fixed on left and right sides of atrial septum, respectively and smoothly released without displacement or falling off and the delivery system and the delivery system is successfully withdrawn.

  2. Device-related AE (adverse event) rates [ Time Frame: 5 years post operation ]
    AE refers to adverse medical events occurring during clinical trial no matter if they are device-related

  3. Device-related SAE (serious adverse event) rates [ Time Frame: 5 years post operation ]
    SAE refers to events occurring in the clinical trial that can lead to death or serious health deterioration, including fatal disease or injure, permanent defects of body structure or function, need for hospitalization or prolonging hospitalization time or medial or operation intervention to avoid permanent defects of body structure or body function, fetal distress, fetal death or congenital anomaly, congenital defects.



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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601039


Contacts
Contact: Xie Yumei, MD 86-13600058803 xymay@126.com

Locations
China, Beijing
Pan Xiangbin Not yet recruiting
Beijing, Beijing, China
Contact: Pan Xiangbin         
China, Chongqing
Yi Kaijian Not yet recruiting
Chongqing, Chongqing, China
Contact: Yi Kaijian         
China, Guangdong
Zhang Zhiwei Recruiting
Guangzhou, Guangdong, China
Contact: Zhang Zhiwei         
China, Heilongjiang
Yu Bo Not yet recruiting
Harbin, Heilongjiang, China
Contact: Yu Bo         
China, Henan
Fan Taibing Not yet recruiting
Zhenzhou, Henan, China
Contact: Fan Taibing         
China, Hunan
Fang Zhenfei Not yet recruiting
Changsha, Hunan, China
Contact: Fang Zhenfei         
China, Jiangsu
Kong Xiangqing Not yet recruiting
Nanjing, Jiangsu, China
Contact: Kong Xiangqing         
China, Shanghai
Chen Sun Not yet recruiting
Shanghai, Shanghai, China
Contact: Chen Sun         
Li Fei Not yet recruiting
Shanghai, Shanghai, China
Contact: Li Fei         
China, Shenzhen
Liu Cong Not yet recruiting
Shenzhen, Shenzhen, China
Contact: Liu Cong         
China, Zhejiang
Gong Fangqi Not yet recruiting
Hangzhou, Zhejiang, China
Contact: Gong Fangqi         
Sponsors and Collaborators
Lifetech Scientific (Shenzhen) Co., Ltd.

Publications:
Jie Ren. Biodegradable Poly(Lactic Acid): Synthesis, Modification, Processing and Applications. Tsinghua University Press, Beijing and Springer-Verlag Berlin Heidelberg 2010
Catia Bastioli. Handbook of Biodegradable Polymers. Rapra Technology Limited Shawbury, Shrewsbury, Shropshire, SY4 4NR, UK.
Lakshmi S. Nair, Cato T. Laurencin. Biodegradable polymers as biomaterials. Prog. Polym. Sci. 32 (2007) 762-798.

Responsible Party: Lifetech Scientific (Shenzhen) Co., Ltd.
ClinicalTrials.gov Identifier: NCT03601039     History of Changes
Other Study ID Numbers: 42CT(CN)
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lifetech Scientific (Shenzhen) Co., Ltd.:
Absnow Absorbable Occluder
ASD Occluder

Additional relevant MeSH terms:
Heart Septal Defects
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities