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Nickel Allergy With Septal Closure Devices

NCT01068366 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 4

Last updated 2013-05-15

No results posted yet for this study

Summary

This study is for patients who have been diagnosed with either a Patent Foramen Ovale \[PFO\] or an Atrial Septal Defect \[ASD\]. These are a type of hole located in the wall that separates the top two (2) chambers of the heart. You have been recommended to receive an atrial septal occluder device \[a device specifically designed to close PFOs and ASDs\] implanted in your heart to close this hole. Because these devices are made of materials that contain nickel, this trial is being conducted to perform blood nickel tests on those patients already referred for an atrial septal occluder device such as yourself. The purpose of this study is to compare levels of nickel in the blood in patients receiving either the Amplatzer or the Helex devices.

Conditions

  • Atrial Septal Defect
  • Patent Foramen Ovale
  • Allergic Reaction to Nickel

Sponsors & Collaborators

Principal Investigators

  • Andrew D. Michaels, MD · University of Utah

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01068366 on ClinicalTrials.gov