NCT00583596

Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 436 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

AGA-004 - The objective of the study is to determine safety, effectiveness and clinical utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus. AGA-007 - The objective of this study is to evaluate the long term safety and effectiveness issues that may not have have been adequately addressed during AGA-004.

Conditions

• Patent Ductus Arteriosus (PDA)

Interventions

Type	Name	Description
DEVICE	Device closure with AMPLATZER Duct Occluder	Device closure with AMPLATZER Duct Occluder
OTHER	Objective Performance Criteria	Compare results of device closure to objective performance criteria

Timeline

• Start date: 1999-10-01
• Primary completion: 2008-04-01
• Completion: 2009-02-01
• First posted: 2007-12-31
• Last updated: 2023-06-29
• Results posted: 2014-07-18

Locations

24 sites across 1 country: United States