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SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
Sponsor: Abbott Medical Devices
Summary
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.
Official title: A Single Arm, Non-randomized, Multi-center Clinical Study of the SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
20
Start Date
2019-10-24
Completion Date
2028-10
Last Updated
2025-02-11
Healthy Volunteers
No
Conditions
Interventions
Aortic Valve Replacement
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
Locations (13)
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
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
Deutsches Herzzentrum München des Freistaates Bayern
München, Bavaria, Germany
Herzzentrum Leipzig GmbH
Leipzig, Saxony, Germany
Medizinische Hochschule Hannover
Hanover, Germany