Safety and Efficacy Study of Absnow Absorbable ASD Closure System For Treating ASD Patients (NCT03601039) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy Study of Absnow Absorbable ASD Closure System For Treating ASD Patients
China165 participantsStarted 2018-08-25
Plain-language 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.
Who can participate
Age range3 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 affec…
What they're measuring
1
Effective Closure Rate at 360-day Post Operation
Timeframe: 360-day post ASD closure operative
2
The Rate of Common Complication During 360-day Post ASD Closure Operative