Closure of Atrial Septal Defects With the AMPLATZERâ„¢ Septal Occluder (ASO) Post Market Surveillance Study
Closure of Atrial Septal Defects With the AMPLATZERâ„¢ Septal Occluder (ASO) Post Market Surveillance Study
Prospective, multicenter, case-cohort study.To identify potential risk factors associated with the occurrence of erosion due to implantation of the AMPLATZERâ„¢ 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.
Inclusion Criteria:
To participate in this clinical investigation, the patient must meet all of the following inclusion criteria:
Exclusion Criteria:
Patient is not eligible for clinical investigation participation if he/she meets any of the following exclusion criteria:
Houston, Texas 77030, United States