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OpenTrials
Completed

NCT Number: NCT00650936

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

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

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Key information

Conditions

Atrial Septal Defect Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

AMPLATZER Septal Occluder

Device

AMPLATZER Septal Occluder

Primary outcomes

  1. Percent of Subjects With Two-year Device-related Hemodynamic Compromise

    Time frame: 24 months

    The primary efficacy endpoint was the two-year incidence rate of device-related hemodynamic compromise.

  2. Co-Primary Effectiveness Endpoint

    Time frame: 24 months

    The percentage of subjects for whom closure success is achieved through two-years. To meet this endpoint, two criteria must be met:

    Technical Success: Successful deployment of the device percutaneously Closure Success: Closure of the atrial septal defect (i.e., a shunt < 2mm) without the need for surgical repair

  3. Co-Primary Safety Endpoint

    Time frame: 24 months

    The co-primary safety endpoint was the percentage of subjects experiencing a device or delivery system related adverse event

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Apr 2, 2008
Registry last updated
Jul 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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