AMPLATZER Duct Occluder II Additional Sizes

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Diagnosis of a PDA
PDA ≤ 4mm in diameter
PDA ≥ 3mm in length
Subject (or legally authorized representative) is willing to comply with all pre-procedure, post-procedure, and follow-up testing requirements and provides consent to participate in the clinical study

NOTE: This study is enrolling children and all local laws and governing IRB requirements will be followed for obtaining informed consent

Exclusion Criteria

Weight < 700 grams at time of the procedure
Age < 3 days at time of procedure
Coarctation of the aorta
Left pulmonary artery stenosis
Cardiac output that is dependent on right to left shunt through the patent ductus arteriosus due to pulmonary hypertension
Intracardiac thrombus
Active infection requiring treatment at the time of implant
Female subjects of child bearing potential are either pregnant or desire to become pregnant within six months post implant
Other disease process likely to limit survival to less than six (6) months
Participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints

Arm && Interventions

Group	Intervention	Description
PDA closure	ADO II AS (PDA closure)	-

Primary Outcome Measures

Name	Time	Method
Effectiveness Endpoint: The Rate of Effective Closure of the Ductus Arteriosus Among Subjects With a Successful ADO II AS Implant	At the 6-month follow-up	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).
Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant	Through 180 days	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

Secondary Outcome Measures

Name	Time	Method
The Rate of Significant Obstruction of the Pulmonary Artery or Aorta	Through 6 month follow-up visit	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.

Locations (9): Nationwide Children's Hospital
🇺🇸
Columbus, Ohio, United States
Children's Hospital of Philadelphia
🇺🇸
Philadelphia, Pennsylvania, United States
Texas Children's Hospital
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Houston, Texas, United States
Seattle Children's Hospital
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Seattle, Washington, United States
St. Louis Children's Hospital
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Saint Louis, Missouri, United States
Methodist LeBonheur Healthcare
🇺🇸
Memphis, Tennessee, United States
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