AMPLATZER Duct Occluder II Clinical Study
This trial is active, not recruiting.
|Condition||patent ductus arteriosus|
|Treatment||amplatzer duct occluder ii|
|Sponsor||St. Jude Medical|
|Start date||August 2008|
|End date||October 2011|
|Trial size||192 participants|
|Trial identifier||NCT00713700, CL00233|
The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|San Diego, CA||Children's Hospital and Health Center||no longer recruiting|
|San Francisco, CA||University of California San Francisco Hospital||no longer recruiting|
|Aurora, CO||The Children's Hospital - Denver||no longer recruiting|
|Wilmington, DE||Alfred I. DuPont Hospital for Children -Nemours Cardiac Center||no longer recruiting|
|Washington, DC, DC||Children's National Medical Center||no longer recruiting|
|Hollywood, FL||Memorial Regional Hospital (Joe DiMaggio Children's Hospital)||no longer recruiting|
|Atlanta, GA||Children's Healthcare of Atlanta||no longer recruiting|
|Indianapolis, IN||Riley Hospital for Children||no longer recruiting|
|Boston, MA||Children's Hospital Boston||no longer recruiting|
|Minneapolis, MN||University of Minnesota||no longer recruiting|
|Jackson, MS||University of Mississippi Medical Center||no longer recruiting|
|St. Louis, MO||Washington University School of Medicine||no longer recruiting|
|Bronx, NY||The Children's Hospital Montefiore||no longer recruiting|
|New York, NY||Mount Sinai School of Medicine||no longer recruiting|
|Cincinnati, OH||Cincinnati Children's Hospital Medical Center||no longer recruiting|
|Cleveland, OH||The Children's Hospital at Cleveland Clinic||no longer recruiting|
|Columbus, OH||Nationwide Children's Hospital||no longer recruiting|
|Philadelphia, PA||The Children's Hospital of Philadelphia||no longer recruiting|
|Charleston, SC||Medical University of South Carolina||no longer recruiting|
|Nashville, TN||Vanderbilt Children's Hospital||no longer recruiting|
|Dallas, TX||University of Texas SW Medical Center||no longer recruiting|
|Houston, TX||Texas Children's Hospital||no longer recruiting|
|Salt Lake City, UT||Primary Children's Medical Center||no longer recruiting|
|Seattle, WA||Children's Hospital and Regional Medical Center||no longer recruiting|
|Milwaukee, WI||Children's Hospital of Wisconsin||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure.
time frame: 180 days
The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up.
time frame: 180 days
Male or female participants from 6 months up to 18 years old.
Inclusion Criteria: - Subject must have diagnosis of a PDA - Subject must have a PDA < 5.5mm in diameter by angiography - Subject must have a PDA < 12mm in length by angiography - Subject must have a PDA > 3mm in length by angiography - Subject/legally authorized representative must give consent to participate in the clinical study - Subject/legally authorized representative must consent to follow-up for the duration of the clinical study Exclusion Criteria: - Subject must not be < 6 kilograms for the procedure - Subject must not be < 6 months of age - Subject must not be ≥ 18 years of age - Subject must not have a descending aorta < 10mm in diameter - Subject must not have a right to left shunt through the patent ductus arteriosus - Subject must not have PVR above 8 Woods units or a Rp/Rs >0.4 - Subject must not have intracardiac thrombus - Subject must not have additional cardiac anomalies requiring surgical or interventional correction - Subject must not have history of more than two lower respiratory infections within the last year (i.e., pneumonia) - Subject must not have active infection requiring treatment at the time of implant - Subject must not have contraindication to anticoagulation treatment - Female subjects of child bearing age must not be pregnant or desire to become pregnant within six months post implant* - Subject must not be participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints - If the subject desires to become pregnant after six months post-implant, further restriction is at the discretion of their physician.
|Official title||Closure of Patent Ductus Arteriosus With the AMPLATZER DUCT Occluder II|
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