The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
192
AMPLATZER Duct Occluder II
The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure.
The primary safety endpoint is the rate of device and/or procedure related SAEs reported in subjects whom device placement is attempted from the procedure through 180 days post procedure SAEs are defined as: Adverse events resulting in the following; death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospital stay, persistent or significant disability/incapacity or medically significant event.
Time frame: 180 days
The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up.
The primary efficacy endpoint is the rate of complete closure of the ductus arteriosus as assessed by the absence of residual flow and continuous murmur at the six-month follow-up by transthoracic echocardiography and physical exam respectively.
Time frame: 180 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Children's Hospital and Health Center
San Diego, California, United States
University of California San Francisco Hospital
San Francisco, California, United States
The Children's Hospital - Denver
Aurora, Colorado, United States
Alfred I. DuPont Hospital for Children -Nemours Cardiac Center
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Memorial Regional Hospital (Joe DiMaggio Children's Hospital)
Hollywood, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Children's Hospital Boston
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
...and 15 more locations