Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study

Recruiting in Palo Alto (17 mi)

+50 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Abbott Medical Devices

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder

Research Team

Eligibility Criteria

Inclusion Criteria

is indicated for implantation with the AMPLATZER Septal Occluder for occlusion of a secundum atrial septal defect (Note: This does not include the indication for closure of a fenestration following a fenestrated Fontan procedure)

is willing and able to complete the follow-up requirements of this study,

signs the informed consent (or a legal representative signs the informed consent)

Treatment Details

Interventions

AMPLATZER Septal Occluder (Septal Occluder)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: AMPLATZER Septal OccluderExperimental Treatment1 Intervention

Subjects were enrolled if the implant of the AMPLATZER Septal Occluder device was completed or was attempted (delivery system entered the subject's body).