ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study (ASO 522)
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ClinicalTrials.gov Identifier: NCT02353351
Recruitment Status :
(The sponsor's study closure justification addressed the 522 Order's questions.)
Prospective, multicenter, case-cohort study.To identify potential risk factors associated with the occurrence of erosion due to implantation of the AMPLATZER™ Septal Occluder (ASO.)
Condition or disease
Atrial Septal Defect Secundum
Device: atrial septal occluder
This study will enroll 8000 subjects. The sub-cohort will consist of 160 (2%) subjects, randomly selected from the full cohort. The analysis population will consist of all subjects in the sub-cohort, combined with all subjects with erosion events who are not in the sub-cohort. A detailed assessment of risk factors will be conducted on the subjects in this analysis population.
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Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement).
The subject population includes vulnerable patients.
To participate in this clinical investigation, the patient must meet all of the following inclusion criteria:
Patient indicated for ASD closure who has echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement) and is implanted with the ASO device Note: This does not include the indication for closure of a fenestration following a fenestrated Fontan procedure
Patient is willing and able to complete the follow-up requirements of this study
Patient signs the informed consent (or a legal representative signs the informed consent.)
Patient is not eligible for clinical investigation participation if he/she meets any of the following exclusion criteria:
Patient is known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery
Patient is known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement
Patient is known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy (unless another anti-platelet agent can be administered for 6 months)
Patient is known to have a demonstrated intracardiac thrombus on echocardiography
Patient whose size (such as, too small for transesophageal echocardiography probe, catheter size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization
Patient has margins of defect that are less than 5 mm to the coronary sinus, AV valves or right upper lobe pulmonary vein