Nickel Allergy With Septal Closure Devices
Nickel Allergy With Septal Closure Devices
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.
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.
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.