The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
AMPLATZER Septal Occluder
Percent of Subjects With Two-year Device-related Hemodynamic Compromise
The primary efficacy endpoint was the two-year incidence rate of device-related hemodynamic compromise.
Time frame: 24 months
Co-Primary Effectiveness Endpoint
The percentage of subjects for whom closure success is achieved through two-years. To meet this endpoint, two criteria must be met: Technical Success: Successful deployment of the device percutaneously Closure Success: Closure of the atrial septal defect (i.e., a shunt \< 2mm) without the need for surgical repair
Time frame: 24 months
Co-Primary Safety Endpoint
The co-primary safety endpoint was the percentage of subjects experiencing a device or delivery system related adverse event
Time frame: 24 months
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