EP Lab Digest - October 2007 - (Page 19)

OCTOBER CLINICAL TRIAL UPDATE Title: Paroxysmal Atrial Fibrillation: Role of Inflammation, Oxidative Stress and Effect of Statins Number of Patients: 130 Trial Start Date: April 2006 Trial End Date: Expected completion in December 2010 Status: Recruiting Purpose: The purpose of this randomized, double-blind, placebo-controlled study is to follow the serum markers for inflammation and oxidative stress and to determine their effect, as well as the effect of statin therapy, for prevention of atrial fibrillation in patients, with or without a pacemaker, who have a history of paroxysmal atrial fibrillation in the absence of significant coronary artery disease. Phase: II Contact: Anne M. Gillis, MD, Principal Investigator, University of Calgary (amgillis@ucalgary.ca); Henry J. Duff, MD, Study Director, University of Calgary; Derek V. Exner, MD, MPH, Study Director, University of Calgary; Katherine Kavanagh, MD, Study Director, University of Calgary; L.B. Mitchell, MD, Study Director, University of Calgary; Robert S. Sheldon, MD, PhD, Study Director, University of Calgary; D.G. Wyse, MD, PhD, Study Director, University of Calgary; George Veenhuyzen, MD, Study Director, University of Calgary Title: Treatment of Atrial Fibrillation by Minimal Invasive Epicardial Pulmonary Vein Isolation: The ABOLISH-AF Study Number of Patients: 15 Trial Start Date: June 2006 Trial End Date: Expected completion in May 2009 Status: Recruiting Purpose: The purpose of this nonrandomized, uncontrolled study is to determine the feasability of a new epicardial and minimally invasive ablation technique of the left atrium isolating the pulmonary veins for prevention of atrial fibrillation recurrences in patients with antiarrhythmic drug refractory lone atrial fibrillation. Phase: II Contact: Isabelle C. Van Gelder, MD, Principal Investigator, University Medical Centre Groningen, the Netherlands (i.c.van.gelder@thorax.umcg.nl) Title: Pediatric Lead Extractability and Survival Evaluation (PLEASE) Study: A Prospective Assessment of Implantable Cardioverter Defibrillator (ICD) Lead Extractability and Survival in Children and Congenital Heart Disease Patients Number of Patients: 300 Trial Start Date: June 2006 Trial End Date: Expected completion in June 2011 Status: Recruiting Purpose: This is a randomized, prospective clinical trial comparing two different models of implantable cardioverter-defibrillator (ICD) leads in children and patients with congenital heart disease. ICD lead survival in this patient group is particularly suboptimal, and lead extraction is technically difficult and carries a substantial morbidity risk. Recently, improved ICD lead designs have been released and are currently being utilized in patients. The main aim of the study is to determine if either type of lead performs better in terms of implantation electrical characteristics, long-term survival without breaking, and ease of extractability. Phase: IV Contact: Charles I Berul, MD, Principal Investigator, Children's Hospital Boston, Massachusetts (charles.berul@ cardio.chboston.org) Title: Open, Prospective, Randomized Trial Comparing Trigger vs. Substrate vs. Hybrid Approaches for AF Ablation Number of Patients: 90 Trial Start Date: August 2006 Trial End Date: Expected completion in August 2008 Status: Recruiting Purpose: The purpose of this randomized, active-controlled study is to compare a trigger-based technique (pulmonary vein isolation) to a substrate-based technique (high-frequency, fractionated EGMs) to a combined approach for AF ablation. Phase: IV Contact: Atul Verma, Dr., Principal Investigator, Southlake Regional Health Center, Newmarket, Ontario, Canada (atul.verma@utoronto.ca) Title: First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment: A Multi-Center Randomized Trial Number of Patients: 400 Trial Start Date: August 2006 Trial End Date: August 2009 Status: Recruiting Pur pose: The pur pose of this randomized study is to determine whether catheter-based pulmonary vein isolation is superior to antiarrhythmic drugs as first line therapy in patients with symptomatic paroxysmal recurrent atrial fibrillation not previously treated with therapeutic doses of antiarrhythmic drugs. Phase: III Contact: Carlos A. Morillo, MD, Principal Investigator, Population Health Research Institute, Hamilton Health Sciences Corporation and McMaster University (morillo@hhsc.ca); Andrea Natale, MD, Principal Investigator, The Cleveland Clinic Title: Efficacy of Different Ablation Strategies in Achieving Long-Term Arrhythmia Control in Patients With Persistent or Permanent Atrial Fibrillation Number of Patients: 147 Trial Start Date: October 2006 Trial End Date: Projected enrollment completion in Fall 2008 Status: Recruiting Purpose: The aim of this research is to compare efficacy of pulmonary vein isolation (PVI) combined with ablation of documented non-PV triggers of atrial fibrillation (AF) versus PVI combined with empiric ablation of either common sites of nonPV triggers of AF or areas that demonstrate complex fractionated electrograms (CFE) on long-term (12 months) arrhythmia control in patients with persistent or permanent AF. Hypothesis: Pulmonary vein isolation combined with empiric ablation of either common sites of nonPV triggers of AF or areas that demonstrate complex fractionated electrograms should be more efficacious than PVI combined with ablation of only documented non-PV triggers of AF in achieving long-term arrhythmia control in patients with persistent or permanent AF. Contact: Sanjay Dixit, MD, Principal Investigator, University of Pennsylvania (sanjay.dixit@uphs.upenn.edu) Title: A Randomized Trial to Assess the Utility of Empirical Anti-Arrhythmic Drug Therapy to Prevent Atrial Arrhythmia During the 6 Weeks Following Pulmonary Vein Isolation to Treat Paroxysmal Atrial Fibrillation Number of Patients: 168 Trial Start Date: November 2006 Status: Recruiting Purpose: The purpose of this randomized, uncontrolled study is to examine the overall effectiveness of anti-arrhythmic medicines prescribed after an ablation procedure for atrial fibrillation. Contact: Edward P. Gerstenfeld, MD, Principal Investigator, University of Pennsylvania Health System - Cardiac Electrophysiology, Pennsylvania (email N/A) Title: Omega-Three Fatty Acids for the Prevention of Atrial Fibrillation After Cardiac Surgery Number of Patients: 250 Trial Start Date: February 2007 Trial End Date: Expected completion in April 2008 Status: Recruiting Purpose: The primary objective of this randomized, double-blind, placebo-controlled trial is to determine if omega-3 polyunsaturated fatty acids reduce atrial fibrillation after cardiac surgery, decrease postoperative complication rates, and decrease intensive care unit and hospital length-of-stay. Phase: IV Contact: Chirag M. Sandesara, MD, Principal Investigator, University of Iowa Hospitals and Clinics, Iowa City, Iowa (chirag-sandesara@uiowa.edu); Brian Olshansky, MD (brian-olshansky@ uiowa.edu) Title: Randomized Comparison of Ablation Devices Used During Surgery for the Treatment of Atrial Fibrillation Number of Patients: 100 Trial Start Date: April 2007 Trial End Date: Expected completion in May 2009 Status: Recruiting Purpose: The purpose of this randomized study is to compare six different devices currently used to treat atrial fibrillation (AtriCure dry bipolar radiofrequency clamp; Boston Scientific’s FLEX 10 unipolar microwave antenna; CryoCath SurgiFrost unipolar cryothermic probe; ESTECH Cobra Adhere irrigated unipolar RF antenna; Medtronic’s Cardioblate BP irrigated bipolar RF clamp; St. Jude Medical’s Epicor hiintensity focused ultrasound wand), and follow up after surgery to determine if any one device is best. Phase: 0 Contact: Adam E. Saltman, MD, Principal Investigator, Director of Atrial fibrillation Program, Cardiothoracic Surgeon, Maimonides Medical Center, Brooklyn, New York See CLINICAL TRIAL UPDATE page 20

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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