EP Lab Digest - March 2008 - (Page 27)

MARCH 2008 EP RESEARCH 27 digoxin. Phase: III Contact: Karen kgibbs@cw.bc.ca Gibbs, RN, Title: Ablation of Inappropriate Sinus Tachycardia Syndrome by Targeting Cardiac Neural Input Number of Patients: 25 Trial Start Date: April 2004 Trial End Date: Estimated Study Completion Date: January 2010; Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure) Status: Recruiting Purpose: We hypothesize that radiofrequency ablation, targeting the sympathetic input of the sinus node identified by 20Hz stimulation in the right atrium and superior vena cava, will effectively reduce sinus rate acutely and reduce palpitations due to inappropriate sinus tachycardia without the need for pacemaker implantation due to sinus node dysfunction post ablation. Contact: Deborah J. Lockwood, MD, Principal Investigator, University of Oklahoma Health Sciences Center, d e b o r a h - l o c k wo o d @ o u h s c. e d u , Caroline Hilferink-Lenaerts, RN, MPH, CCRP, carolinehilferink@ouhsc.edu Ventricular Fibrillation Title: An International, Randomized, Controlled Pre-hospital Trial of a Waveform-Based Automated External Defibrillation Algorithm for the Management of Ventricular Fibrillation Number of Patients: 1,000 Trial Start Date: May 2006 Trial End Date: April 2009 Purpose: This study is designed to examine the impact of an available technology within an automated external defibrillator (AED) to improve survival following out-ofhospital cardiac arrest for patients presenting in ventricular fibrillation. Contact: John P. Freese, MD, Principal Investigator, New York City Fire Department, Dawn Jorgenson, PhD, Study Director, Philips Medical Systems. Title: IN-TIME: Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function Number of Patients: 620 Trial Start Date: July 2007 Trial End Date: Estimated Study Completion Date: July 2010; Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure) Status: Recruiting Purpose: Re-hospitalizations or deaths by worsening heart failure are often preceded by distinct trends of clinical parameters such as atrial or ventricular arrhythmia, activity, heart rate variability, or ventricular ectopy. The Home Monitoring™ capability offered by BIOTRONIK active implants has the potential to detect some of these trends early and thus offer the possibility to intervene in time for prevention of fatal worsening of heart failure. To investigate the predictive value of Home Monitoring parameters, patients with symptomatic heart failure and reduced ejection fractions receiving an implantable cardiover terdefibrillator (ICD) or an ICD in combination with cardiac resynchronization therapy (CRT-D) will be randomized between prospective patient management by Home Monitoring analysis or standard care. The influence of Home Monitoring on the clinical status of heart failure patients will be assessed using the Packer score, a combined endpoint of death, hospitalization, NYHA class and global self assessment. Phase: IV Contact: Heinrich Moertel, PhD, heinrich.moertel@biotronik.com Other Clinical Trials in the News: Boston Scientific Announces Results of Comparative Study of Defibrillator Leads Boston Scientific Corporation announced that results of its defibrillator lead study, known as REFLEx, were published in the January issue of PACE. The study compared the company’s ENDOTAK RELIANCE® G Gore™-coated leads to non-coated leads. RELIANCE G leads have a proprietary GORE™ ePTFE coating designed to prevent tissue ingrowth.Tissue ingrowth can make lead removal more difficult. Medical literature suggests up to 10 percent of leads may eventually need to be removed. REFLEx (The RELIANCE G Evaluation of Handling and Electrical Performance Study) was a prospective, multi-center, non-inferiority, randomized study that enrolled 1,115 patients at 111 centers. The results of the study demonstrate that ENDOTAK RELIANCE G defibrillation leads performed as well as comparative leads with respect to electrical performance. Results were inconclusive regarding an additional study objective related to the termination of spontaneous tachyarrhythmias given a limited set of patient events. “Because Boston Scientific is the only company to offer a Gore ePTFEcoated lead, it is important that we thoroughly research the effect of Gore ePTFE coating on lead performance,” said Dr. Arjun Sharma, Vice President, Clinical Sciences and Chief Patient Safety Officer, Boston Scientific CRM. “The results of this study should give physicians assurance that they can gain the intended benefits of the RELIANCE G lead with no tradeoff in lead performance.” Study results were authored by lead investigator Dr. Bruce Koplan at Brigham and Women’s Hospital in Boston. The Food and Drug Administration approved the ENDOTAK RELIANCE G lead in March 2004. To date, there are 81,000 registered U.S. implants. For more information, please visit: http://clinicaltrials.gov/ Visit EP Lab Digest at the ACC.08! The 57th Annual Scientific Sessions of the American College of Cardiology will be taking place March 29-April 1 in Chicago, Illinois. Will you be attending? If so, we hope to see you there! Please stop by and see us at booth #19093! http://clinicaltrials.gov/ http://www.wavemark.net http://www.wavemark.net

Table of Contents Feed for the Digital Edition of EP Lab Digest - March 2008

EP Lab Digest - March 2008 ECG 101: The Case of a Dizzy Patient with a Left Bundle Branch Block Delayed Defibrillation: Research and Results Interview with Paul S. Chan, MD Contents Letter from the Editor Spotlight Interview: St. Joseph’s Hospital Health Center Parent Heart Watch from 36,000 Feet… Perspectives from the Annual Leadership Conference Clinical Trial Overview: 2008 Are MRI-Safe Pacemakers and Leads on the Horizon? Q & A with J. Rod Gimbel, MD Navigating Tortuous Coronary Sinus Anatomy Using a Bipolar Lead Email Discussion Group: March 2008 Guidelines on ECG Interpretation Spotlight Interview Update: What Have We Learned? The Value of Educating Staff Events Calendar Industry News and Products Classifieds Advertisers Index In Memoriam

EP Lab Digest - March 2008

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