NASAH: Nickel Allergy With Septal Closure Devices

Sponsor

University of Utah (Other)

Overall Status

Terminated

CT.gov ID

NCT01068366

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Septal Defect Patent Foramen Ovale Allergic Reaction to Nickel

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.

Study Design

Study Type:

Observational

Actual Enrollment :

4 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Nickel Allergy With Septal Occluder Using Amplatzer and Helex Devices (NASAH) Trial

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Outcome Measures

Primary Outcome Measures

The difference in serum nickel levels [1 month post device implantation]

Secondary Outcome Measures

Device allergic syndrome [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.