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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT00650936
First received: March 31, 2008
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Atrial Septal Defect
Device: AMPLATZER Septal Occluder

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by AGA Medical Corporation:

Primary Outcome Measures:
  • The primary objective is to evaluate the risk of hemodynamic compromise in patients who receive the AMPLATZER Septal Occluder device. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The co-primary objective is to assess the safety and effectiveness of the AMPLATZER Septal Occluder device and delivery system. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: August 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I Device: AMPLATZER Septal Occluder
AMPLATZER Septal Occluder

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650936

  Show 51 Study Locations
Sponsors and Collaborators
AGA Medical Corporation
  More Information

No publications provided

Responsible Party: AGA Medical Corporation
ClinicalTrials.gov Identifier: NCT00650936     History of Changes
Other Study ID Numbers: AGA-014
Study First Received: March 31, 2008
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by AGA Medical Corporation:
Atrial
Septal
Defect

Additional relevant MeSH terms:
Heart Septal Defects
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 28, 2014