Clinical trial NCT01068366: Nickel Allergy With Septal Closure Devices
Official title: Nickel Allergy With Septal Occluder Using Amplatzer and Helex Devices (NASAH) Trial
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atrial Septal Defect
Patent Foramen Ovale
Allergic Reaction to Nickel
Keywords: Nickel Allergic Syndrome
Septal Closure Devices
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2010-02-12
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients already scheduled for ASD or PFO closure with Amplatzer or Helex devices.

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.

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 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.

Primary outcomes:
measure: The difference in serum nickel levels
timeFrame: 1 month post device implantation
Secondary outcomes:
measure: Device allergic syndrome
timeFrame: 1 month
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Andrew D. Michaels, MD
role: PRINCIPAL_INVESTIGATOR
References: