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

NCT00583596 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 436

Last updated 2023-06-29

Study results available
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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

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

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-10-31
Primary Completion
2008-04-30
Completion
2009-02-28

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00583596 on ClinicalTrials.gov