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.)
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.
Study Type
OBSERVATIONAL
Enrollment
602
Single arm atrial septal defect closure with the AMPLATZER Septal Occluder
Cumulative incidence of cardiac erosion
Cumulative incidence of erosion will be reported as: • The number of erosions per 8000 subjects.
Time frame: 1 year
Aortic Rim Measurements (< 5 mm, ≥ 5 mm)
Time frame: 1 year
Atrio-Ventricular (AV) Valve Rim Measurements (< 5 mm, ≥ 5 mm)
Time frame: 1 year
Superior Vena Cava (SVC) Rim Measurements (< 5 mm, ≥ 5 mm)
Time frame: 1 year
Inferior Vena Cava (IVC) Rim Measurements (< 5 mm, ≥ 5 mm)
Time frame: 1 year
Other Evaluable Rim Measurements (< 5 mm, ≥ 5 mm)
Time frame: 1 year
Ratio of Defect Size (Diameter) to Septal Length (< 0.5:1, ≥ 0.5:1)
Time frame: 1 year
Ratio of Defect Size (Diameter) to Septal Width (< 0.5:1, ≥ 0.5:1)
Time frame: 1 year
Device Splaying the Aorta (Yes, No)
Time frame: 1 year
Device Impingement of the Aorta (Yes, No)
Time frame: 1 year
Device Abutting the Aorta (Yes, No)
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Alabama
Birmingham, Alabama, United States
University of Arizona
Tucson, Arizona, United States
University of Arkansas
Little Rock, Arkansas, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
University of Southern California
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Huntington Memorial Hospital
Pasadena, California, United States
...and 55 more locations
Age (< 14, ≥ 14 years)
Time frame: 1 year
Gender (Male, Female)
Time frame: 1 year
Device Size Implanted (< 18 mm, ≥ 18 mm)
Time frame: 1 year
Device Size to Defect Size (< 1.5:1, ≥ 1.5:1)
Time frame: 1 year
Body Surface Area (<1.5 m2 and ≥ 1.5m2)
Time frame: 1 year