EP Lab Digest - December 2007 - (Page 24)

24 CLINICAL TRIALS DECEMBER 2007 About the PRECEDE-HF Trial: Interview with William T. Abraham, MD, FACP, FACC, FAHA Interview by Jodie Elrod This trial will determine if the knowledge of these measures can help keep patients alive and out of the hospital for longer periods of time. studies, decreases in these measures have been seen preceding hospitalizations for heart failure. This trial will determine if the knowledge of these measures can help keep patients alive and out of the hospital for longer periods of time. The total suite of diagnostics is also unique. How many heart failure related hospitalizations take place each year at your institution? We have about 1,000 heart failure hospitalizations each year at the Ohio State University Medical Center. Is there any learning curve when using this technology? For clinicians, shared experience among many investigators should help mitigate any learning curve. I n this article, we learn about the Prospective, Randomized Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure (PRECEDE-HF) trial, which is now enrolling patients. Dr. Abraham, Professor of Medicine and Chief of the Division of Cardiovascular Medicine at the Ohio State University Medical Center, is the principal investigator in this trial. enrolled; however, the trial may end before this enrollment is complete, as it is an event-driven trial. This means that the trial ends when a critical number of total events (death from any cause or first heart failure hospitalization) occurs. What do you find promising about this technology? The promising aspect of this technology is that it may give us early warning to impending episodes of worsening heart failure well before symptoms occur, and therefore allow us to keep patients out of the hospital. Pending results of the PRECEDE-HF trial, how will the Cardiac Compass and OptiVol Fluid Status Monitoring technologies change the treatment and outlook of heart failure? Cardiac Compass with OptiVol Fluid Status monitoring has already changed the way we view heart failure. We now know that for many patients, their health can slowly worsen over many days to weeks. This is reflected in physiological changes that can be detected by Cardiac Compass with OptiVol Fluid Status monitoring and help us better manage our patients. Describe the PRECEDE-HF trial. What is the purpose of the trial? PRECEDE HF is the first large, randomized, controlled trial to evaluate the utility of implantable device-based monitoring technologies in heart failure. It has been designed and prospectively powered to determine if the use of standard clinical assessment plus Cardiac Compass with OptiVol Fluid Status monitoring improves outcome (reduces the combined endpoint of heart failure hospitalization and allcause mortality) compared to standard clinical assessment alone. The study will be conducted at up to 100 centers in the United States and up to 15 centers in Canada to meet study enrollment needs in a timely manner. Up to 2,550 subjects will be enrolled. Enrollment will continue until either sufficient events to analyze the primary objectives have been obtained or the maximum amount of subjects has been enrolled. How does the Cardiac Compass with OptiVol Fluid Status Monitoring differ from other remote monitoring products available today? Cardiac Compass with OptiVol Fluid Status monitoring is unique in that it is the only FDA-approved system for intrathoracic impedance monitoring. Who is eligible to enroll in this trial? The trial is intended to recruit "real world" patients. Any adult heart failure patient who has a Medtronic device that includes Cardiac Compass with OptiVol Fluid Status monitoring and who has had an episode of worsening heart failure requiring intravenous treatment in the past 12 months is potentially eligible. Next Month’s Issue: Readers, there is still time to submit your article for our January 2008 issue of EP Lab Digest. Remember, this issue will be distributed at the Boston Atrial Fibrillation Symposium! To have your submission considered for publication, please email your article to “jelrod@hmpcommunications.com”. Describe the Cardiac Compass with OptiVol Fluid Status Monitoring technology. How do these features work? What patient data do they help gather? Cardiac Compass with OptiVol Fluid Status monitoring measures several physiological parameters that may aid in the determination of a patient's clinical status. Such parameters include patient activity level, heart rate variability, and intrathoracic impedance (displayed as the OptiVol Fluid Index). In prior What are the start and end dates? The study began in the Fall of 2007. The duration of the study depends on enrollment and event rates. The study may last as long as five years, but it is likely to conclude sooner. As noted above, up to 2,550 subjects may be

Table of Contents Feed for the Digital Edition of EP Lab Digest - December 2007

EP Lab Digest - December 2007 Improved Anatomical Orientation During AF Catheter Ablation: Experience from Leipzig Heart Center One EP Lab’s Solution to the Administration of Deep Sedation Contents Letter from the Editor Spotlight Interview: Northeast Georgia Medical Center Emerging Technologies for the Electrophysiology Lab The Western Atrial Fibrillation Symposium About the PRECEDE-HF Trial: Interview with William T. Abraham, MD, FACP, FACC, FAHA Overview on Shire and the Discontinuation of Ethmozine®: After the Heart Rhythm Society Intervenes, the Company Changes its Decision Minimizing the Risk of Infection at Children’s Sibley Heart Center: Interview with Nicole Jarrell, RNC, MSN, and J. Renee Watson, RN, CIC Is There a Link Between Gasoline Vapors and Brugada Syndrome? Interview with Darko Kranjcec, MD and Hugues Abriel, MD, PhD New Feature! Pacemaker/ICD Puzzle Email Discussion Group Events Calendar Industry News and Products

EP Lab Digest - December 2007

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.