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 range
3 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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