The objectives of the study are:
* To determine the efficacy of the Figulla Flex II device compared with that of the Amplatzer ASO device for transcatheter closure of secundum atrial septal defects
* To determine the safety of the Figulla Flex II device compared with that of the Amplatzer ASO device for transcatheter closure of secundum atrial septal defects
This is a randomized, controlled, multi-centre trial of the efficacy and safety of the Occlutech septal occluder (Figulla Flex II) compared to the AGA septal occluder (Amplatzer ASO) for transcatheter closure of secundum atrial septal defects in patients.
Who can participate
SexALL
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
✓. Able to fluently speak and understand the language in which the study is being conducted
✓. Has ostium secundum atrial septal defect
✓. Has a defect hole with a diameter of \< 38 mm
✓. Has a left-to-right shunt with a Qp/Qs ratio of ≥ 1.5:1 or the presence of right ventricular volume overload determined by transthoracic echo (TTE) or clinical symptoms due to the atrial septal defect
✓. Has a distance of \> 5 mm from the margins of the defect(s) to the coronary sinus, arterioventricular (AV) valves and right upper pulmonary vein as measured by echocardiography
✓. Agrees to participate in the study and comply with the follow-up schedule
✓. Is willing to freely give (or Legally Authorized Representative is willing to freely give) Informed Consent prior to treatment
✓. Willing to return for the post-treatment evaluation
Exclusion criteria
✕. Has multiple defects which can't adequately be covered by the device
✕. Has associated congenital cardiac anomalies which require cardiac surgery
✕. Patient is currently participating in another clinical device or drug trial that has not completed its primary endpoint or that will clinically confound the current study endpoints or does not permit subjects to participate in other studies. Typically, subjects that are involved in the long-term surveillance phase of a clinical study are eligible.
What they're measuring
1
Efficacy: the rate of a successful placement of the device
Timeframe: the day after procedure but no later than 36 hours after the procedure.
2
Efficacy:The secondary efficacy endpoint is the rate of closure success (residual shunt is smaller than or equal to 2 mm) within 6 months after the procedure, without the need for surgical repair.
Timeframe: within 6 months after the procedure
3
Efficacy:Other efficacy endpoint was the rate of complete closure (no residual shunt) at 6 months after the procedure.
✕. Has partial anomolous pulmonary venous drainage
✕. Has pulmonary vascular resistance above 7 Woods units or a right-toleft shunt at the atrial level with a peripheral arterial saturation less than 94%
✕. Has a recent myocardial infarction, unstable angina and decompensated congestive heart failure (CHF)