Starfix® Left Ventricular Lead Extraction Study

Study Summary

The University of Chicago and Dr. Burke are conducting a research study to evaluate lead removal success in patients who have a Cardiac Resynchronization Therapy System (CRT) device and are indicated for left ventricular lead removal. This study is required by the Food and Drug Administration (FDA).

The purpose of the study is to find out if the Medtronic StarFix® LV lead can be removed safely as compared to the removal of other Medtronic LV leads. The LV lead is the only part of your CRT system that is being studied.

We will collect information that pertains to your procedure. You will be in this study for approximately 1 month from when your LV lead is removed.

You will not personally benefit from participating in this study. However, the information gained from this study may assist in the design of new product(s)/therapy(ies) or instructions that may benefit others in the future.

Participation Details

Initial selection criteria include:

• Medtronic left ventricular lead and indication for removal of lead
• Must be at least 18 years of age
• 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

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

IRB: #16902A