Research Study for Patients Receiving an Implantable Cardioverter-Defibrillator or Cardiac Resynchronization Therapy Device

Study Summary

The University of Chicago and Dr. Beshai are conducting a study for people who are scheduled or have recently received a dual-chamber implantable cardioverter-defibrillator (ICD) device or cardiac resynchronization therapy (CRT-D) device. The study objective is to determine if early awareness of an abnormal heart rhythm with Home Monitoring in combination with anticoagulation (blood thinning) medication is able to reduce the risk of stroke, systemic blood clots, and major bleeding episodes in patients implanted with dual-chamber ICD or CRT-D.

For the purposes of this study, you will be assigned to one of two groups. One group will have Home Monitoring "fully enabled," meaning the study doctor will be able to use the HM and Online-IEGM features of your ICD or CRT-D and will have continuous monitoring of your heart rate and rhythm as well as your device. The other group will have the HM device “on” but not fully enabled. This means that your study doctor will not be able to see how your heart and study device are functioning using the HM and Online-IEGM features of your device.

Your participation in this study is expected to last no longer than three years. However, the study (from start to finish) is expected to last approximately six years. You will be asked to visit the clinic every three months for as long as you are in the study.

You may or may not benefit from participation however we hope early diagnosis and treatment of abnormal atrial heart rhythms may reduce your risk of stroke and systemic embolism (a blood clot which becomes stuck in the artery). The results of this study may also benefit other patients. However, these benefits cannot be guaranteed.

Participation Details

Initial selection criteria include:

• Must be at least 18 years of age
• Able and willing to follow anticoagulation therapy if needed during the course of the study
• Must be available for clinic visits for the duration of the study
• Must meet study medical criteria as evaluated by Dr. Beshai

Study Director: Dr. John Beshai
Department: Cardiology

For more information contact:
Melissa Byrn
(773) 834-7157
mbyrn@medicine.bsd.uchicago.edu

IRB: #16471A