EP Lab Digest - October 2007 - (Page 20)

CLINICAL CLINICAL TRIAL UPDATE Continued from page 19 TRIAL UPDATE OCTOBER (asaltman@maimonidesmed.org); Kamran B. Ali, MD, Principal Investigator, Cardiology Fellow (kali@maimonidesmed.org) Title: The Sibling Concordance for Implantable CardioverterDefibrillator 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 crosssectional 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) In the News: Medtronic Presents Key Clinical Evidence at European Society of Cardiology Congress In conjunction with the European Society of Cardiology Congress being held in Vienna,Austria, September 1-5, 2007, Medtronic, Inc. announced results from several clinical studies regarding the treatment and management of heart failure patients, as well as post-myocardial infarction (MI) patient risk stratification.The clinical evidence presentations follow closely on CE Mark receipt for the Medtronic CareLink® Network and its capabilities of remotely and wirelessly monitoring heart failure patients with implantable cardiac devices in 14 countries around the world. SEARCH-MI SEARCH-MI (Survey to Evaluate Arrhythmia Rate in So-Called High Risk MI Patients) is a prospective, observational, multicenter study to document the incidence and prevalence of implantable cardioverter-defibrillator (ICD) interventions and ventricular arrhythmias for European ICD patients with a previous MI.These patients received ICDs as primary prevention because they were considered at risk for sudden cardiac arrest (SCA), but had not previously experienced a dangerous ventricular arrhythmia.The study was conducted at 69 centers and enrolled 788 patients who were followed for an average of two years. SEARCH-MI was presented by Prof. Giuseppe Boriani, MD, PhD, of Institute of Cardiology, University of Bologna and Azienda Ospedaliera S.Orsola-Malpighi in Bologna, Italy. Results demonstrated that approximately one in five study participants benefited from successfully treated ventricular arrhythmic events by their ICD.The event rates are similar to those reported for the ICD arm of the MADIT II Trial, which studied a North American primary prevention population. Patients in the trial were also implanted with cardiac resynchronization therapy (CRT) devices, tailored to the needs of heart failure patients. Clinical Trial Update 2008: Readers, look for continued coverage of cardiac electrophysiology related clinical trials in future issues. In addition, for more information about any of these trials, or if you would like to see information about a particular clinical trial included in EP Lab Digest, please email the editor at “jelrod@hmpcommunications.com”. CARISMA CARISMA (Cardiac Arrhythmias and Risk Stratification After Myocardial Infarction) is a multicenter study to investigate the ability of selected invasive and non-invasive tests, performed six weeks after an acute myocardial infarction (AMI), to predict an ICD-“treatable” arrhythmia. Presented as a Poster Session, CARISMA documented the incidence of cardiac arrhythmias using the Medtronic Reveal® Plus insertable loop recorder (ILR) and demonstrated the utility of heart rate variability parameters as appropriate risk stratifier for post-MI patients. PROSPECT PROSPECT (Predictors of Response to CRT) is a prospective, multicenter study that evaluates the ability of selected baseline echocardiographic parameters to predict clinical or echocardiographic response to CRT. Within Medtronic’s clinical evidence portfolio, additional studies investigating acute myocardial infarction are underway. Further, the company’s focus on heart failure includes clinical research into Medtronic’s proprietary OptiVol® Fluid Status Monitoring, which measures changes in intrathoracic impedance. Using very low electrical pulses that travel across the thoracic cavity, the system can measure the level of resistance to the electrical pulses, which indicates the level of fluid in the thorax. Since normal fluid levels may vary from patient to patient and fluid accumulation can be either slow or rapid, OptiVol’s ability to measure fluid status trends over time can provide important insights in conjunction with ongoing monitoring of other patient symptoms.The heart failure research includes, among others, SENSE-HF and DOT-HF: In the News: CryoCor Completes Enrollment of Pivotal Clinical Study for Atrial Fibrillation CryoCor, Inc., a medical device company focused on the treatment of cardiac arrhythmias, announced the completion of enrollment of its pivotal clinical study for the treatment of atrial fibrillation. “This is a major milestone for CryoCor, being the first company to complete enrollment in a randomized pivotal study for the use of ablation for the treatment of atrial fibrillation,” said Ed Brennan, PhD, Chief Executive Officer of CryoCor. “With the recent approval of our cryoablation system for the treatment of right atrial flutter, in the fourth quarter, we will begin placing our system at high-volume ablation centers across the U.S., familiarizing physicians with our system and establishing our installed base of consoles in anticipation of approval for the treatment of atrial fibrillation in 2009.” Helen Barold, MD, Chief Medical Officer of CryoCor, said, “I am very pleased with the progress we have made with this study and look forward to fully analyzing the data.We continue to see an excellent safety profile for our cryoablation device and expect to file a PMA in late 2008. At this point we will begin our non-randomized continued access protocol in which patients will be enrolled into the ablation arm. ” CryoCor has enrolled over 170 patients in its pivotal clinical study and will complete a 12-month follow-up for each patient. SENSE-HF SENSE-HF (Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure) is a prospective, observational, multicenter, event-driven, international study to evaluate the sensitivity and positive predictive value of the OptiVol® Fluid Trends data in predicting HF-related hospitalizations and health care utilizations associated with the signs and symptoms of worsening heart failure. DOT-HF DOT-HF (Diagnostic Outcome Trial in Heart Failure) is a prospective, randomized, multicenter, event-driven, international study to investigate if there is a reduction in the combined endpoint of heart failure hospitalizations and all-cause mortality in subjects randomized to “Access Arm” compared to “Control Arm” subjects. Access Arm patients are managed with standard clinical assessment and are using OptiVol Fluid Status Monitoring with Cardiac Compass® Reports; Control Arm patients are managed with standard clinical assessment alone.

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

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.