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

Abbott

Status: Completed

Conditions: Atrial Septal Defect

Treatments: Device: AMPLATZER Septal Occluder

Study type: Interventional

Funder types: Industry

Identifiers

NCT00650936

AGA-014

Details and patient eligibility

About

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

Enrollment: 1,000 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients must meet all inclusion criteria. A patient meets inclusion criteria if he/she:

  • 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, and
  • signs the informed consent (or a legal representative signs the informed consent).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

1,000 participants in 1 patient group

AMPLATZER Septal Occluder

Other group

Description:

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

Treatment:

Device: AMPLATZER Septal Occluder