Status:
COMPLETED
AMPLATZER Duct Occluder II Clinical Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Patent Ductus Arteriosus
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2016
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT00713700
Start Date
August 1 2008
End Date
October 5 2016
Last Update
February 4 2019
Active Locations (25)
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1
Children's Hospital and Health Center
San Diego, California, United States, 92123
2
University of California San Francisco Hospital
San Francisco, California, United States, 94143-0544
3
The Children's Hospital - Denver
Aurora, Colorado, United States, 80045
4
Alfred I. DuPont Hospital for Children -Nemours Cardiac Center
Wilmington, Delaware, United States, 19803