Nickel Allergy With Septal Closure Devices (NASAH)

This study has been terminated.
(PI re-located.)
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01068366
First received: February 11, 2010
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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.


Condition
Atrial Septal Defect
Patent Foramen Ovale
Allergic Reaction to Nickel

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Nickel Allergy With Septal Occluder Using Amplatzer and Helex Devices (NASAH) Trial

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • The difference in serum nickel levels [ Time Frame: 1 month post device implantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Device allergic syndrome [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: February 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Detailed Description:

This is a single-center, single-operator, investigator-initiated, investigator-funded, open-label, non-randomized cohort study. Inclusion criteria include patients ≥18 years, secundum atrial septal defect (ASD) ≤1cm 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. After device implantation, routine clinical followup will be performed, including transthoracic echocardiography at 1 day, 1 month, and 6 months, and 48-Holter monitoring for arrhythmia at 1 month.

Research related study procedures are blood draws to measure nickel levels and a patient questionnaire about symptoms. Blood draws will be done at baseline [from the femoral venous sheath immediately prior to device implantation] and at one (1) day, one (1) month, three (3) months and six (6) months. The Questionnaire will be completed at one (1) month, three (3) months and six (6) months but can be done over the telephone if patient is having blood drawn at a lab closer to their home. Patient participation is complete after collection of the 6 month blood results and patient questionnaire.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068366

Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Andrew D. Michaels, MD University of Utah
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01068366     History of Changes
Other Study ID Numbers: 38813
Study First Received: February 11, 2010
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Nickel Allergic Syndrome
Septal Closure Devices

Additional relevant MeSH terms:
Heart Septal Defects
Foramen Ovale, Patent
Hypersensitivity
Heart Septal Defects, Atrial
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014