Study Involving Patients Undergoing an ICD/CRT-D

Study Summary

The University of Chicago Medical Center and Dr. Martin Burke are conducting a study involving patients undergoing implantation of an implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy device with defibrillator (CRT-D). The purpose of the study is to collect heart signals through the electrical wires placed into your heart chambers and, simultaneously, selected areas on your skin around your left chest during your clinically indicated device implantation procedure. These recordings are similar to the tracings that you may have seen on your electrocardiogram (EKG). All of these recordings will be simultaneously collected and digitally saved in a database that will be used to develop the next generation of heart device capable of sensing heart beats and defibrillating the heart when necessary. The study data is collected only at the time of your procedure and follow up for the study is not needed. You will be implanted only with an ICD or CRT-D that is approved by the Food and Drug Administration (FDA).

You will be asked to return seven to 14 days after implantation, as is routine, for follow-up wound check and device interrogation in the cardiac device clinic as part of your normal course of care.

You will receive no direct benefit by participating in this study.

Participation Details

Initial selection criteria include:

• Must be at least 18 years of age
• Must not be pregnant
• Must meet study medical criteria as evaluated by Dr. Burke and his team

Study Director: Dr. Martin Burke
Department: Cardiology/Clinical Cardiac Electrophysiology

For more information contact:
Melody Huntley
(773) 834-7157

IRB: #14113B