Clinical Trial Update: 2007

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 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: 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 non-randomized, 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 Purpose: The purpose 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 non-PV 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 non-PV 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 hi-intensity 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 (asaltman@maimonidesmed.org); Kamran B. Ali, MD, Principal Investigator, Cardiology Fellow (kali@maimonidesmed.org) Title: The Sibling Concordance for Implantable Cardioverter-Defibrillator Therapies in Ischemic Cardiomyopathy Study Number of Patients: 2,145 Trial Start Date: August 2007 Trial End Date: Expected completion in December 2008 Status: Recruiting Purpose: The purpose of this cross-sectional study is to determine if genetic factors influence the risk of life-threatening heart rhythms (i.e., ventricular tachycardia and ventricular fibrillation) after myocardial infarction. Phase: Observational Contact: Patrick M. Hranitzky, MD, Principal Investigator, Duke University, North Carolina; Jonathan P. Piccini, MD, Principal Investigator, Duke University, North Carolina (picci004@ mc.duke.edu) Title: A Randomized Clinical Trial of Prevention of Post Ablation Recurrence of Atrial Fibrillation With Angiotensin Receptor Blockers Number of Patients: 310 Trial Start Date: January 2008 Trial End Date: Expected completion in July 2011 Status: Not yet open for patient recruitment Purpose: The aim of this randomized, double-blind, placebo-controlled study is to test whether the use of angiotensin receptor blockers (versus placebo) will reduce the rate of recurrent AF after catheter ablation for AF or atrial flutter. Phase: IV Contact: Ratika Parkash, MD MSc, Principal Investigator, Dalhousie University/QEII HSC, Halifax, Nova Scotia, Canada (parkashr@cdha.nshealth.ca)