EP Lab Digest - October 2007 - (Page 18)

18 CLINICAL TRIAL UPDATE OCTOBER 2007 Clinical Trial Update: 2007 Compiled by Jodie Elrod B elow is a sampling of some of the active EP-related clinical trials currently taking place. the influence of different types of atrial fibrillation on silent strokes and the related impairment in cognitive functions. Other risk factors and cardiovascular diseases that are known to provoke the development of strokes will be assessed as well. Contact: Stefan Knecht, Prof., Principal Investigator, University Hospital Münster, Department of Neurology, Germany (knecht@uni-muenster.de) Title: Medtronic Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF)/Permanent AF Study Arm and a Persistent AF Study Arm Number of Patients: 75 patients Permanent AF Study; 75 patients Persistent AF Study Trial Start Date: November 2004 Trial End Date: Expected completion in December 2009 Status: Recruiting Purpose: This is a prospective, nonrandomized multicenter trial evaluating the outcome of patients with atrial fibrillation requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. Phase: III Contact: Ralph Damiano, MD, Principal Investigator, Washington University School of Medicine, St. Louis, Missouri; A. Marc Gillinov, MD, Principal Investigator, The Cleveland Clinic, Cleveland, Ohio (emails N/A) Title: Angiotensin II-Antagonist in Paroxysmal Atrial Fibrillation Trial (ANTIPAF Trial) Number of Patients: 422 Trial Start Date: January 2005 Trial End Date: September 2008 Status: Recruiting Purpose: The purpose of this randomized, double-blind study is to block the angiotensin II type 1 receptor (using Olmesartan) to help reduce the incidence of atrial fibrillation episodes in patients with paroxysmal atrial fibrillation, and then compare the results to standard medication without an angiotensin II type 1 receptor. Phase: III Contact: Andreas Goette, MD, Principal Investigator, University Hospital Magdeburg (andreas.goette@ medizin.uni-magdeburg.de); Thomas Meinertz, MD, Principal Investigator, University Hospital Hamburg Title: Effect of Supplemental Intake of Omega-3 Polyunsaturated Fatty Acids on the Rate and Complexity of Spontaneously Occurring Ventricular and Supraventricular Arrhythmias in Patients With Implantable Cardioverter Defibrillators (ICDs) – A Randomized Clinical Trial Number of Patients: 112 Trial Start Date: November 2005 Trial End Date: Expected completion in January 2008 Status: Recruiting Purpose: The authors of this randomized, double-blind study hypothesize that oral supplementation with omega-3 PUFA will decrease occurrence of arrhythmic events among post-MI, ICD recipients. Phase: IV Contact: David Luria, MD, Principal Investigator, Sheba Medical Center, Israel (david.luria@sheba.health.gov.il); Sami Viskin, MD, Sorasky Medical Center,Tel-Aviv, Israel Title: Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension, Permanent Pacemakers and Risk Factors for Developing Atrial Fibrillation Number of Patients: 200 Trial Start Date: December 2005 Trial End Date: Expected completion in July 2008 Status: Recruiting Purpose: The purpose of this randomized, double-blind study is to determine whether the drug irbesartan (compared to placebo) will reduce the rate of recurrent atrial high rate episodes and the development of clinical sustained atrial fibrillation in patients with hypertension and permanent pacemaker. Phase: III Contact: Stuart J. Connolly, MD, Principal Investigator, Hamilton Health Sciences (connostu@hhsc.ca); Jeffrey S. Healey, MD, Principal Investigator, Hamilton Health Sciences (healeyj@ hhsc.ca); Carlos A. Morillo, MD, Principal Investigator, Hamilton Health Sciences; Stefan H. Hohnloser, MD, Principal Investigator, J.W. Goethe University, Frankfurt, Germany; Carsten W. Israel, MD, Principal Investigator, J.W. Goethe University, Frankfurt, Germany Title: MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure Number of Patients: 1,300 Trial Start Date: February 2006 Trial End Date: Expected completion in December 2009 Status: Recruiting Purpose: The purpose of this randomized, single-blind study is to test the impact of the managed ventricular pacing (MVP) mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical outcome composed of any death, permanent atrial fibrillation, and cardiovascular hospitalizations. Phase: IV Contact: Luigi Padeletti, Prof., Principal Investigator, Ospedale Careggi - Firenze; Dr. Giuseppe Boriani, Principal Investigator, Ospedale Sant'Orsola Bologna; Dr. Luis Mont, Principal Investigator, Hospital Clinic - Barcelona; Dr. Reinhard C. Funck, Principal Investigator, Philipps University Hospital - Marburg; Dr. Carsten W. Israel, Principal Investigator, J.W. Goethe University Hospital - Frankfurt; Dr. Helmut Pürerfellner, Principal Investigator, Elisabethinen Hospital Linz; Antonis S Manolis, Prof., Principal Investigator, Evagelismos Hospital Athens; Dr. André Pisapia, Principal Investigator, Hôpital Saint-Joseph Marseille; Dr. Raymond Tukkie, Principal Investigator, Kennemer Gasthuis - Haarlem (emails N/A) Title: A Randomized Study That Will Show the Effects of Catheter Ablation Compared to the Effects of Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation Number of Patients: 200 Trial Start Date: March 2006 Trial End Date: Possible completion in 2010 Status: Recruiting Purpose: The purpose of this randomized, uncontrolled study is to compare a conventional ablation approach, where lesions are created on the inside of the heart, with a thoracoscopic approach, where the lesions are created from the outside of the heart. Contact: Jesper H. Svendsen, MD, Principal Investigator, Rigshospitalet, Copenhagen, Denmark (hastrup@rh.dk) Title: Pacing the Octogenarian Plus Population (POPP): A Comparison of Physiologic Versus Ventricular Pacing in Those Who Are 80 Years of Age and Older Number of Patients: 200 Trial Start Date: August 2003 Trial End Date: Expected completion in August 2009 Status: Recruiting Purpose: Of the 19,000 pacemakers implanted across Canada in 2002, one-third of them were implanted in patients 80 years and older. Unfortunately, no study has specifically been done in this age group to determine the optimal pacing mode. This purpose of this study is to determine which pacing mode, physiologic or ventricular, is associated with a reduction in emergency room visits or hospitalizations for cardiovascular causes (e.g., congestive heart failure, atrial fibrillation), resulting in improved quality of life. Contact: Anne M. Gillis, MD, Principal Investigator, Director of Pacing and Electrophysiology, Professor of Medicine, University of Calgary, Canada; Derek V. Exner, MD, MPH, Study Director, University of Calgary, Canada; D. George Wyse, MD, PhD, Study Director, University of Calgary, Canada; L. Brent Mitchell, MD, Study Director, University of Calgary, Canada; Robert S. Sheldon, MD, PhD, Study Director, University of Calgary, Canada; John M. Rothschild, MD, Study Director, University of Calgary, Canada; Henry J. Duff, MD, Study Director, University of Calgary, Canada; John Burgess, MD, Study Director, University of Calgary, Canada; Alexander Bayes, MD, Study Director, University of Calgary, Canada (emails N/A) Title: Atrial Fibrillation and the Risk for Neurological Complications Number of Patients: 1,000 Trial Start Date: January 2004 Trial End Date: 2009 Status: Recruiting Purpose: The purpose of this longitudinal, prospective study aims at evaluating

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

Finally! The New Registered Cardiac Electrophysiology Specialist (RCES) Credential: Interview with Christopher M. Nelson, RN, RCIS, FSICP ECG 101: Closing the Gap Phenomenon Contents Letter from the Editor ICD Patient Support Group: St. Peter’s Hospital Spotlight Interview: Community Healthcare System Use of Magnetic Catheter Navigation for Ablation of Focal Tachycardias Echocardiography: The Preeminent Front Line Screening and Diagnostic Tool for Cardiovascular Imaging and Physiological Assessment First Annual EP Lab Digest Salary Survey: Last Chance! Clinical Trial Update: 2007 Email Discussion Group Adopting and Implementing the AF Ablation Consensus Statement Electrophysiology in the West Summit Events Calendar The Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) Clinical Trial: Interview with Kevin Wheelan, MD Industry News and Products

EP Lab Digest - October 2007

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