Nickel Allergy With Septal Closure Devices

Stopped early

Conditions studied: Atrial Septal Defect, Patent Foramen Ovale, Allergic Reaction to Nickel

In brief

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.

Key facts

Study ID

NCT01068366

Run by

University of Utah

People needed

4

Starts

2010-02-01

Expected to finish

2010-11-01

Last updated by the study team

2013-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients ≥ 18 years,
• Secundum atrial septal defect (ASD) ≤ 1 cm on transesophageal echocardiography or patent foramen ovale (PFO), without contraindications to antiplatelet and/or antithrombotic therapy, and
• Suitable anatomy for device closure with one of the following: Amplatzer atrial septal occluder, Amplatzer Cribriform septal occluder, Amplatzer PFO occluder, or the Gore Helex septal occluder.

Where it is running

• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.