The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized clinical investigation to characterize the safety and effectiveness of the ADO II AS device in patients with a patent ductus arteriosus (PDA). Subjects will be implanted with the ADO II AS device using a transcatheter femoral vessel approach under fluoroscopic and echocardiographic guidance. To account for subject dropout, up to 50 subjects will be enrolled in this clinical investigation. Up to an additional 150 subjects may be enrolled under continued access. The clinical investigation will be conducted at up to 10 centers in the United States. Subjects participating in this clinical investigation will be followed for 3 years. The expected duration of enrollment is 18 months. The total duration of the clinical investigation is expected to be 4.5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
Cedars Sinai Medical Center
Los Angeles, California, United States
Arnold Palmer Hospital
Orlando, Florida, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Methodist LeBonheur Healthcare
Memphis, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant
Major complications are defined as device (ADO II AS) or procedure-related adverse events resulting in any of the following: * death, * life-threatening adverse event, * persistent or significant disability/incapacity, and/or * a major open surgical intervention which is performed by a surgeon under general anesthesia
Time frame: Through 180 days
Effectiveness Endpoint: The Rate of Effective Closure of the Ductus Arteriosus Among Subjects With a Successful ADO II AS Implant
The primary effectiveness endpoint is the rate of effective closure of the ductus arteriosus among subjects with a successful ADO II AS implant as assessed by the presence of either a Grade 0 (none) or Grade 1 (trivial) shunt at the 6-month follow-up by transthoracic echocardiography (TTE).
Time frame: At the 6-month follow-up
The Rate of Significant Obstruction of the Pulmonary Artery or Aorta
The rate of significant obstruction of the pulmonary artery or aorta through the 6-month follow-up visit per the following definitions: 1. Significant obstruction of the left pulmonary artery is defined as less than 30% flow to the left lung by lung perfusion scan or a peak instantaneous gradient in left pulmonary artery ≥35 mmHg by echocardiogram if lung perfusion scan is not available. OR 2. Significant obstruction of the aorta is defined as a gradient of ≥20 mmHg in the aortic isthmus by invasive aortic catheterization or a mean gradient ≥20 mmHg in the aortic isthmus by echocardiogram if invasive aortic catheterization is not available.
Time frame: Through 6 month follow-up visit
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