This PAS is an observational, non-randomized, multi-center, single arm, clinical study to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve (15 AHPJ-505) as a replacement device for pediatric patients with a diseased, damaged, or malfunctioning aortic valve.
Study Type
OBSERVATIONAL
Enrollment
20
SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve as a replacement device for patients with a diseased, damaged, or malfunctioning aortic valve
Children's Hospital Los Angeles (USC)
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
Sutter Medical Center, Sacramento
Sacramento, California, United States
Rate of total serious valve-related adverse events
actuarial (Kaplan-Meier) rate of total serious valve-related adverse events experienced through 5 years post implant or until the valve is removed/replaced. Valve-related adverse events to be evaluated are: * Death; * Endocarditis; * Hemorrhage (whether or not due to anticoagulant/antiplatelet medication); * Nonstructural dysfunction (including perivalvular leak, hemolysis, and hemolytic anemia); * Reoperation (including valve explant, not due to anatomical growth of the subject); * Structural valve deterioration; * Thromboembolism * Valvular thrombosis
Time frame: 5 Years
Peak gradient as assessed by echocardiography
Peak gradient as assessed by echocardiography at 30 Days, 6 Months, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
Time frame: Up to 5 years
Mean gradient as assessed by echocardiography
Mean gradient as assessed by echocardiography at 30 Days, 6 Months, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
Time frame: Up to 5 years
Valvular regurgitation as assessed by echocardiography
Valvular regurgitation as assessed by echocardiography at 30 Days, 6 Months, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year
Time frame: Up to 5 years
Number of all-cause deaths
Time frame: 1 Year
Number of valve-related deaths
Time frame: 1 Year
Number of reoperations or explants excluding replacement due to somatic growth
Time frame: 1 Year
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Variety Children's Hospital
Miami, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Dell Children's Medical Center
Austin, Texas, United States
Children's Medical Center Dallas
Dallas, Texas, United States
Sana - Herzchirurgische Klinik Stuttgart GmbH
Stuttgart, Baden-Wurttemberg, Germany
...and 3 more locations