Study Results
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View full resultsBasic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2017-06-05
2022-04-05
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PDA closure
ADO II AS (PDA closure)
Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
Interventions
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ADO II AS (PDA closure)
Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
3 Days
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Evan Zahn, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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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
Countries
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References
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Morray BH, Sathanandam SK, Forbes T, Gillespie M, Berman D, Armstrong AK, Shahanavaz S, Jones T, Rockefeller T, Justino H, Nykanen D, Weiler C, Gutfinger D, Zahn EM. 3-year follow-up of a prospective, multicenter study of the Amplatzer Piccolo Occluder for transcatheter patent ductus arteriosus closure in children >/= 700 grams. J Perinatol. 2023 Oct;43(10):1238-1244. doi: 10.1038/s41372-023-01741-1. Epub 2023 Aug 16.
Sathanandam SK, Gutfinger D, O'Brien L, Forbes TJ, Gillespie MJ, Berman DP, Armstrong AK, Shahanavaz S, Jones TK, Morray BH, Rockefeller TA, Justino H, Nykanen DG, Zahn EM. Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients >/=700 grams. Catheter Cardiovasc Interv. 2020 Nov;96(6):1266-1276. doi: 10.1002/ccd.28973. Epub 2020 May 20.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SJM-CIP-10171
Identifier Type: -
Identifier Source: org_study_id
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