Nickel Allergy With Septal Closure Devices

NCT01068366 | Terminated DMC

• 1 other identifier: 38813
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Nickel Allergic Syndrome; Septal Closure Devices

Outcome Measures

Primary Outcomes (1)

• The difference in serum nickel levels

  1 month post device implantation

Secondary Outcomes (1)

• Device allergic syndrome

  1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients already scheduled for ASD or PFO closure with Amplatzer or Helex devices.

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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Heart Septal Defects, Atrial; Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Andrew D. Michaels, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2010
• First Posted: February 12, 2010
• Study Start: February 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 15, 2013

Record last verified: 2013-05

Locations

US (1)