AMPLATZER Duct Occluder II Clinical Study

Completed · Not applicable

Conditions studied: Patent Ductus Arteriosus

In brief

The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.

Key facts

Study ID: NCT00713700
Run by: Abbott Medical Devices
People needed: 192
Starts: 2008-08-01
Expected to finish: 2016-10-05
Last updated by the study team: 2019-02-04

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Children's Hospital and Health Center — San Diego, California, United States
University of California San Francisco Hospital — San Francisco, California, United States
The Children's Hospital - Denver — Aurora, Colorado, United States
Alfred I. DuPont Hospital for Children -Nemours Cardiac Center — Wilmington, Delaware, United States
Children's National Medical Center — Washington D.C., District of Columbia, United States
Memorial Regional Hospital (Joe DiMaggio Children's Hospital) — Hollywood, Florida, United States
Children's Healthcare of Atlanta — Atlanta, Georgia, United States
Riley Hospital for Children — Indianapolis, Indiana, United States
Children's Hospital Boston — Boston, Massachusetts, United States
University of Minnesota — Minneapolis, Minnesota, United States
University of Mississippi Medical Center — Jackson, Mississippi, United States
Washington University School of Medicine — St Louis, Missouri, United States
Mount Sinai School of Medicine — New York, New York, United States
The Children's Hospital Montefiore — The Bronx, New York, United States
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
The Children's Hospital at Cleveland Clinic — Cleveland, Ohio, United States
Nationwide Children's Hospital — Columbus, Ohio, United States
The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Medical University of South Carolina — Charleston, South Carolina, United States
Vanderbilt Children's Hospital — Nashville, Tennessee, United States
University of Texas SW Medical Center — Dallas, Texas, United States
Texas Children's Hospital — Houston, Texas, United States
Primary Children's Medical Center — Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center — Seattle, Washington, United States
Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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