Study for People Indicated to Receive a CRT-D (Cardiac Resynchronization Therapy-Defibrillator)
Study Summary
Dr. Martin Burke at he University of Chicago is conducting a study to evaluate different pacing modes (how an implanted cardiac device may be programmed to provide pacing to your heart), how these modes may assist your daily activities, and how you are feeling in general. The cardiac resynchronization therapy-defibrillator (CRT-D) used in this study is referred to as the CONTAK RENEWAL® CRT-D family of devices. This CRT-D device is FDA-approved (Food and Drug Administration) and commercially available.
The purpose of this study is to look at different pacing modes (how a device may be programmed to pace your heart), how these modes may assist your daily activities, and how you are feeling There is not much known about the effects of atrial pacing in heart failure patients with CRT devices.
The pacing mode you receive will be picked randomly (like flipping a coin). You will not know which pacing mode has been randomly selected for you, only the sponsor and your medical staff will know which mode has been programmed into your device. Whatever pacing mode you are programmed to, your CRT device will still be able to monitor and treat your heart condition. All three of these programming modes are used in medical practice. No matter which group randomly assigned to you, Dr. Burke will provide you with normal medical care. You will have follow-up visits to the clinic at six weeks, six months, and 12 months, which are within the standard, follow up care. Some of the procedures you will be having are electrocardiogram or EKG (a test to measure the electrical signals that control the rhythm of your heartbeat), questionnaires, device programming, and data collection.
You will not benefit directly from participating in this research. However, information obtained during the course of this clinical research study may contribute to a better understanding of your disease and may be useful in selecting device programming and medicines for your future treatment.
Participation Details
Initial selection criteria include:
- Must be at least 18 years of age
- Must not be pregnant
- Must be available for clinic visits for the duration of the study
- Must meet study medical criteria as evaluated by Dr. Burke
Study Director: Dr. Martin Burke
Department: Cardiology/Clinical Cardiac Electrophysiology
For more information contact:
Melody Huntley
(773) 834-7157
IRB: #13568A
