ST Segment Detection Study

Title: ST Segment Detection Study – (ST DETECT)

Study Sponsor: Medtronic, Inc

Principal Investigator: William Katsiyiannis, MD

Study Synopsis: We are participating in a clinical research study involving the Medtronic Virtuoso ICD (internal cardiac defibrillator).   An ICD is implanted under the skin and has leads (wires) that are connected to the heart tissue. These leads relay information regarding the rhythm of the heart and can deliver a shock to restore normal heart rhythm if needed. These devises are commonly implanted in people with coronary heart disease who might have had a heart attack.

This study uses an ICD that has investigational (or research) software in it. The research software looks to see if heart beat changes occur when the heart is not receiving enough oxygen. This Medtronic Virtuoso ICD has had hardware and software changes in it to record and analyze heart beats and to record heart sounds. Because of these changes, the Medtronic Virtuoso ICD used in this study is investigational. This means it is not yet approved by the FDA and is not available to the general public. The research software will not change how your ICD treats fast and slow heartbeats.

The purpose of this study is to test the accuracy of a software program that detects changes in your heartbeat. The name of the software is the ST Detection Algorithm Software (the “Software”).

The information collected will be helpful in the future development of this type of diagnostic tool. Physicians may be able to better treat their patients with this knowledge.

How do I qualify? If you have been told you need an ICD because of coronary artery disease and have had one of the following:  An acute coronary event within 6 months A stent or other coronary intervention within 1 year.Positive stress test within 1 year. Have residual blockage in your coronary arteries but are not able to have surgery to revascularize them or still have blockage following a revascularization procedure

Study Status: Enrolling

Who do I contact for more information? Karen Meyer, RN or call research at 612.863.3980