EP Lab Digest - March 2008 - (Page 24)

24 EP RESEARCH MARCH 2008 Clinical Trial Overview: 2008 Compiled by Jodie Elrod T he following is a listing of some of the electrophysiologyrelated clinical trials taking place in 2008. Number of Patients: 1,124 Trial Start Date: April 2007 Trial End Date: April 2010 Status: Recruiting Sponsor: National Heart, Lung and Blood Institute Purpose: This randomized study will evaluate the effectiveness of a pacemakerfacilitated beta-blocker therapy to improve outcomes in patients who have recently experienced a heart attack and have bradycardia or AV block contraindications to beta-blocker therapy. Target Population: MI within 30 days (90 days if LVEF acutely is 2 seconds (awake) • PR interval equal to or >260 msec • Type I (Wenckebach) second degree AV block -or2) Documented symptomatic bradycardia due to beta-blockers Why this trial needs your support: • Only a small subset of the acute MI patient population will qualify for this study. This problem occurs in only 5% of the postMI population. While this could represent 75,000 patients per year in the U.S., any one cardiologist will take care of at most a handful of such patients. It is therefore difficult to enroll large numbers of patients at any one site. • This will be the only opportunity to address this important clinical question. Pacemaker implantation for this indication is currently not covered by Medicare. At the present time, pacemaker implantation for this indication (to facilitate beta-blocker therapy in post-MI patients with asymptomatic bradycardia) is not covered by Medicare. If the PACE-MI trial shows benefit to the strategy of pacemaker-facilitated beta-blocker therapy, Medicare will reconsider their decision.This will enable this therapy to be delivered by all physicians in the future to the benefit of their patients. • Your patient referral will improve care in the future. If the strategy of pacemakerfacilitated beta-blocker therapy is beneficial, it is in the long-term interest of a cardiologist (and his/her future patients) to refer a current patient to participate in the trial. Contact: Call 866-929-0990 - the PACE-MI team will facilitate the referral or contact j-cahill@northwestern.edu. All active sites are also listed at http://www.pace-mi.org/. Please complete the patient referral information (found on the Professionals tab). Title: Avoid FFS - Use of the Atrial Pacemaker Lead 1699 With Very Short Tip Ring Spacing to Avoid Far Field Sensing Number of Patients: 170 Trial Start Date: December 2006 Trial End Date: December 2008 Status: Recruiting Purpose: The purpose of this randomized study is to evaluate the possibility to program the shortest possible Post Ventricular Atrial Blanking Period (PVAB) and high sensitivity without getting inappropriate Mode Switch due to Far Field R-Wave sensing when using the new Tendril 1699T lead. Comparison with Tendril 1688T or 1388T with optimized PVAB. Phase: IV Contact: Christof Kolb, MD, kolb@dhm.mhn.de Title: Reducing Episodes by Septal Pacing Efficacy Confirmation Trial (RESPECT) Number of Patients: 400 Trial Start Date: February 2004 Trial End Date: Estimated Study Completion Date: July 2011; Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure). Status: Recruiting Purpose: The purpose of this randomized, single-blind study is to find out if specialized programs in the AT500 and EnRhythm pacemakers will reduce the number of irregular heartbeats in the upper chamber of the heart and reduce symptoms such as shortness of breath, dizziness, and others. Contact: RESPECT Team, Medtronic, medtroniccrmtrials@medtronic.com Title: VIRTUE: Virtual Clinic Pacemaker Follow-up Number of Patients: 120 Trial Start Date: May 2007 Trial End Date: May 2014 Atrial Flutter Title: Randomized Controlled Study of Remote Magnetic Catheter Navigation for Cavotricuspid Isthmus Mapping and Ablation in Patients With Typical Atrial Flutter Number of Patients: 150 Trial Start Date: August 2007 Trial End Date: August 2009 Status: Recruiting Purpose: The purpose of this randomized study is to evaluate the influence of remote magnetic catheter navigation on the safety and efficacy of mapping and radiofrequency ablation of the cavotricuspid isthmus in patients with typical atrial flutter. Contact: Dirk Vollmann, Dr. med., Principal Investigator, Herzzentrum, Abteilung Kardiologie, Universitaetsmedizin Goettingen, dirkvollmann 2000@aol.com, Markus Zabel, Prof. Dr., markus.zabel@med.uni-goettingen.de Title: Multicenter Prospective Randomized Clinical Study Comparing Radiofrequency- vs. Cryo-Ablation in Typical IsthmusDependent Atrial Flutter Number of Patients: 500 Trial Start Date: May 2003 Trial End Date: July 2008 Purpose: This study compares two energy sources (radiofrequency and cryo-ablation) for the catheter-based ablation of typical isthmus-dependent atrial flutter, regarding the acute and long-term efficacy and safety. Contact: Study Chair: Claus Schmitt, MD, Deutsches Herzzentrum Muenchen; Principal Investigator: Bernhard Zrenner, MD Status: Active but not recruiting Purpose: This clinical trial investigates efficacy and safety of the Home Monitoring technology for increasing the flexibility in pacemaker followup. Home Monitoring technology allows automatic transmission via mobile phone links of relevant data from the implanted pacemaker to a service center.The patient's physician can access the data via a passwordprotected Internet site. The regular Home Monitoring data analyses entirely replaces clinical routine visits (i.e., “virtual clinic”). Follow-up visits are scheduled according to the results of the Home Monitoring data analyses. The primary endpoint of this study is to compare the total workload for pacemaker patient care in the virtual clinic with that of standard follow-up scheme with regularly scheduled clinical visits. Phase: IV Contact: Karsten Wallbrück, MS, karsten.wallbrueck@biotronik.com, Ulrike Brand, ulrike.brand@biotronik.com, Dr. David Fluck, Coordinating Clinical Investigator, St. Peter’s Hospital, Chertsey, UK. Brugada Syndrome Title: Cardiac Arrest Survivors With Preserved Ejection Fraction Registry (CASPER) Number of Patients: 200 Trial Start Date: May 2004 Trial End Date: June 2009 Status: Recruiting Purpose: This project will evaluate a standardized testing protocol in detecting the cause of cardiac arrest and familial sudden death in patients with apparently unexplained cardiac arrest. The testing is directed at the detection of rare genetic conditions that result in palpitations, blackouts and sudden death in patients and their family members. Genetic testing will be performed to validate the clinical findings. Phase: III Contact: Andrew D. Krahn, MD, Principal Investigator, London Health Sciences Center and University of Western Ontario, Canada, akrahn@uwo.ca, Bonnie M. Spindler, RN, spindler@uwo.ca Title: Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases Number of Patients: 300 Trial Start Date: October 2003 Bradycardia Title: The PACE-MI Trial: PACEmaker and Beta-Blocker Therapy After Myocardial Infarction http://www.pace-mi.org/

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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