Atrial Septal Defect, Heart Septal Defects, Atrial
Conditions
Keywords
Absnow Absorbable Occluder, ASD Occluder
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.
Interventions
DEVICEAbsnow 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.
Sponsors
Lifetech Scientific (Shenzhen) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
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 who have undergone heart surgery in the past * Patients allergic to PLLA * Patients refusing to sign the informed consent form * Patients with poor compliance on disease-related 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective Closure Rate at 360-day Post Operation | 360-day post ASD closure operative | Effective closure rate refers to proportion of patient without or with only mild-small residual shunt in TTE or TEE observation after device implantation |
| The Rate of Common Complication During 360-day Post ASD Closure Operative | 360-day post operation | Rate of common complication refers to proportion of subject with common complication during the 360day of follow up, common complications include Occluder dislocation, Moderate or larger residual shunt, High-grade atrioventricular block, Intractable headache or migraine, Cardiac tamponade, Cerebral embolism and Air embolism. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immediate Operation Success Rate | Immediate postoperative | Immediate operation success refers to the occluder being 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.Success rate refers to proportion of subject with such implant success. |
| Device-related AE (Adverse Event) Rate | 5 years post operation | This is one of the secondary safety endpoints, device-related AE rate refers to proportion of subject experienced device-related AEs |
| Device-related SAE (Serious Adverse Event) Rate | 5 years post operation | This is one of the secondary safety endpoints, device-related SAE rate refers to proportion of subject experienced device-related SAEs |
Countries
China
Participant flow
Recruitment details
A total of 179 subjects were screened, of which 165 were successfully enrolled.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 16.82 years STANDARD_DEVIATION 17.74 |
| Region of Enrollment China | 161 participants |
| Sex: Female, Male Female | 96 Participants |
| Sex: Female, Male Male | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 164 |
| other Total, other adverse events | 126 / 164 |
| serious Total, serious adverse events | 38 / 164 |
Outcome results
None listed