Atrial Septal Defect Secundum
Conditions
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.
Interventions
DEVICEatrial septal occluder
Single arm atrial septal defect closure with the AMPLATZER Septal Occluder
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
To participate in this clinical investigation, the patient must meet all of the following inclusion criteria: 1. 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 2. Patient is willing and able to complete the follow-up requirements of this study 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of cardiac erosion | 1 year | Cumulative incidence of erosion will be reported as: • The number of erosions per 8000 subjects. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Aortic Rim Measurements (< 5 mm, ≥ 5 mm) | 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 |
| Device Impingement of the Aorta (Yes, No) | 1 year |
Countries
United States
Outcome results
None listed