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AMPLATZER Duct Occluder II Additional Sizes — ADO II AS  

Patent Ductus Arteriosus Clinical Trial

Official title:
AMPLATZER Duct Occluder II Additional Sizes Clinical Study

Clinical Trial Summary

The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized clinical investigation to characterize the safety and effectiveness of the ADO II AS device in patients with a patent ductus arteriosus (PDA). Subjects will be implanted with the ADO II AS device using a transcatheter femoral vessel approach under fluoroscopic and echocardiographic guidance. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03055858
Study type Interventional
Source Abbott Medical Devices
Contact
Status Completed
Phase N/A
Start date June 5, 2017
Completion date April 5, 2022
View Details
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