ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study

Study Overview
=================
Brief Summary
-----------------
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.)

Detailed Description
-----------------
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.

Official Title
-----------------
Closure of Atrial Septal Defects With the AMPLATZER™ Septal Occluder (ASO) Post Market Surveillance Study

Conditions
-----------------
Atrial Septal Defect Secundum

Intervention / Treatment
-----------------
* Device: atrial septal occluder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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.) Exclusion Criteria: 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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: atrial septal occluder|Single arm atrial septal defect closure with the AMPLATZER Septal Occluder|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of cardiac erosion | Cumulative incidence of erosion will be reported as: • The number of erosions per 8000 subjects. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic Rim Measurements (< 5 mm, ≥ 5 mm) |  | 1 year | 
| Atrio-Ventricular (AV) Valve Rim Measurements (< 5 mm, ≥ 5 mm) |  | 1 year | 
| Superior Vena Cava (SVC) Rim Measurements (< 5 mm, ≥ 5 mm) |  | 1 year | 
| Inferior Vena Cava (IVC) Rim Measurements (< 5 mm, ≥ 5 mm) |  | 1 year | 
| Other Evaluable Rim Measurements (< 5 mm, ≥ 5 mm) |  | 1 year | 
| Ratio of Defect Size (Diameter) to Septal Length (< 0.5:1, ≥ 0.5:1) |  | 1 year | 
| Ratio of Defect Size (Diameter) to Septal Width (< 0.5:1, ≥ 0.5:1) |  | 1 year | 
| Device Splaying the Aorta (Yes, No) |  | 1 year | 
| Device Impingement of the Aorta (Yes, No) |  | 1 year | 
| Device Abutting the Aorta (Yes, No) |  | 1 year | 
| Age (< 14, ≥ 14 years) |  | 1 year | 
| Gender (Male, Female) |  | 1 year | 
| Device Size Implanted (< 18 mm, ≥ 18 mm) |  | 1 year | 
| Device Size to Defect Size (< 1.5:1, ≥ 1.5:1) |  | 1 year | 
| Body Surface Area (<1.5 m2 and ≥ 1.5m2) |  | 1 year |