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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by St. Jude Medical.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00650936
First Posted: April 2, 2008
Last Update Posted: February 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by St. Jude Medical:

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 ]

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 ]

Estimated Enrollment: 1000
Study Start Date: August 2007
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I Device: AMPLATZER Septal Occluder
AMPLATZER Septal Occluder

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00650936


  Show 51 Study Locations
Sponsors and Collaborators
St. Jude Medical
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00650936     History of Changes
Other Study ID Numbers: AGA-014
First Submitted: March 31, 2008
First Posted: April 2, 2008
Last Update Posted: February 3, 2015
Last Verified: January 2015

Keywords provided by St. Jude Medical:
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