ADO II Clinical Study - NCT00713700-53226 (Clinical Trial 381825)


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ADO II Clinical Study - NCT00713700-53226 (Clinical Trial 381825)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy381825.aspx

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City:

Milwaukee

State:

Zip Code:

53226

Conditions:

Patent Ductus Arteriosus

Purpose:

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

Study summary:

Criteria:

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.

Study is available at:

Children's Hospital of Wisconsin
Milwaukee, WI 53226
United States

Primary Contact:
Karen Cook
Email: kcook@amplatzer.com
Phone: 763-531-2753

If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.

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Data Source:

ClinicalTrials.gov

Date Processed:

November 16, 2009

Modifications to
this listing:

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Clinical trials are medical research studies designed to test the safety and/or effectiveness of new drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.


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