AMPLATZER Duct Occluder II Additional Sizes

Study Overview
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Brief Summary
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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.

Official Title
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AMPLATZER Duct Occluder II Additional Sizes Clinical Study

Conditions
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Patent Ductus Arteriosus

Intervention / Treatment
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* Device: ADO II AS (PDA closure)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: ADO II AS device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PDA closure<br> | Device: ADO II AS (PDA closure)<br>* Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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). | At the 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: 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 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. | Through 6 month follow-up visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PDA, SJM-CIP-10171, ADO II AS, IDE, CAP