Clinical Trial Overview: 2008

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, Universitaets- medizin 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 Isthmus-Dependent 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 Bradycardia Title: The PACE-MI Trial: PACEmaker and Beta-Blocker Therapy After Myocardial Infarction 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 pacemaker-facilitated 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 -or- 2) 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 post-MI 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 pacemaker-facilitated 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 Status: Active but not recruiting Purpose: This clinical trial investigates efficacy and safety of the Home Monitoring technology for increasing the flexibility in pacemaker follow-up. 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 password-protected 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 Trial End Date: December 2008 Status: Recruiting Purpose: The purpose of this longitudinal, prospective study is the identification of familial congenital arrhythmogenic disorders and their clinical follow-up. Contact: Christian Wolpert, MD, christian.wolpert@med.ma.uni-heidelberg.de, Rainer Schimpf, MD, rainer.schimpf@med.ma.uni-heidelberg.de Long QT Syndrome Title: The Long QT Syndrome in Pregnancy Number of Patients: 12 Trial Start Date: June 2007 Trial End Date: June 2008 Purpose: Our aim is to study as many women who have had a baby who have the long QT syndrome (LQTS) to give us a better idea of whether there are any arrhythmias occurring at the time of delivery. This study will be a retrospective analysis of all LQTS women managed at St. Paul s or BC Women s Hospital who have been pregnant in the last five years. Contact: Areta Wong 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: June 2011 Purpose: This is a randomized, prospective clinical trial comparing two different types 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. Contact: Charles I. Berul, MD, Principal Investigator, Children's Hospital Boston, Frank Cecchin, MD Premature Ventricular Complexes Title: Relativity Study Between Idiopathic Ventricular Arrhythmia and Sex Hormone Levels in Different Stages of Menstrual Cycle Number of Patients: 40 Trial Start Date: January 2008 Trial End Date: December 2008 Status: Recruiting Purpose: The purpose of this observational, prospective study is to determine whether the occurrence of the idiopathic right ventricular outflow tract (RVOT) arrhythmia is relative to sex hormone levels in different stages of the female menstrual cycle. Contact: Xiaopeng Bai, Principal Investigator, bxp007@163.com, Xueqi Li, lixueqi@medmail.com.cn Sudden Cardiac Death Title: Selective Strategy to Manage Arrhythmia Risk and Therapy With ICDs Number of Patients: 5,000 Trial Start Date: October 2007 Trial End Date: April 2011 Purpose: This study will randomize patients with CHD and an ejection fraction between 30-40% to ICD therapy versus no ICD therapy. The primary outcome is mortality, and the study is powered as a non-inferiority trial to test the hypothesis that mortality in patients with no ICD is not more than 1% greater (absolute yearly increase) than patients receiving an ICD. Contact: Paul Dorian, MD and Marta Gadacz, MSc Title: The Role of MMP-9 and MMP-2 in Risk Stratification for VT/VF in Patients With Implanted Cardioverter Defibrillator Devices Number of Patients: 100 Trial Start Date: September 2006 Trial End Date: September 2008 Status: Recruiting Purpose: The primary objective of this cross-sectional study is to assess whether serum levels of MMP 2, 9, and evaluation of the genomic promoter sequence polymorphisms, correlate with episodes of VT/VF in patients who have implantable cardioverter defibrillator devices. Contact: Suzanne Adams, RN, MPH, Suzanne.Adams@jefferson.edu, Dr. Shaw Natan, MD, Shaw.Natan@mail.tju.edu Title: Treatment of Ventricular Tachyarrhythmias Refractory To Shock With Beta Blockers: The SHOCK and BLOCK Trial Number of Patients: 100 Trial Start Date: January 2007 Trial End Date: November 2010 Status: Recruiting Purpose: The purpose of this randomized, double-blind research study is to evaluate the effectiveness of metoprolol, a beta blocker, in treating patients in the hospital with a cardiac arrest. Metoprolol will be given intravenously. The subjects who will take part in this study are 18 years of age or older, are experiencing a cardiac arrest in the hospital, and are in a life-threatening situation. Patients who develop a cardiac arrest require prompt electrical defibrillation to restore the normal beating rhythm of the heart. In patients who do not respond to electrical defibrillation, current standard of care recommends the use of medications that have been shown to be of unknown benefit. Some people recover from a cardiac arrest, but many do not. We want to learn whether giving metoprolol will improve survival of patients with a cardiac arrest. Patients will receive either the standard of care with the drug epinephrine or the standard of care plus metoprolol. Phase: II Contact: William Merhi, DO, Principal Investigator, William Beaumont Hospital, willmerhi@yahoo.com, David E. Haines, MD, Principal Investigator, dhaines@beaumont.edu Title: Effects of Endurance Training on Patients With Reduced LVEF and Cardiac Resynchronization Therapy Especially for Cardiac Arrhythmias Number of Patients: 30 Trial Start Date: August 2007 Trial End Date: December 2008 Status: Recruiting Purpose: A severely reduced left ventricular ejection fraction is associated with increased mortality due to pump failure as well as to malignant ventricular arrhythmia. We hypothesize that targeted training may lead to improved survival and to increased parameters of risk stratification for malignant arrhythmia. Additionally, the training may lead to an improved psychological and mental condition of the patients. Contact: Dirk Müller, MD, PhD, Principal Investigator, Charité, Campus Benjamin Franklin, dr.dirk.mueller@charite.de, Fernando C. Dimeo, MD, PhD, Principal Investigator, Charité, Campus Benjamin Franklin Title: Prospective, Multi-Center Study Of The Ability Of The PD2i Cardiac Analyzer To Predict Risk of VentrIcular TachyArrhythmic Events Such As Sudden Cardiac Death, VentricuLar Fibrillation or Ventricular Tachycardia in High-Risk Patients Number of Patients: 900 Trial Start Date: November 2006 Trial End Date: March 2009 Status: Recruiting Purpose: This is a prospective, longitudinal study evaluating the ability of the PD2i Cardiac Analyzer to predict the risk of serious heart rhythm abnormalities in high-risk patients that do not already have an ICD. Contact: David Fater, dfater@vicortech.com Supraventricular Tachycardia Title: Multicenter Study of Antiarrhythmic Medications for Treatment of Infants With Supraventricular Tachycardia Number of Patients: 220 Trial Start Date: October 2006 Trial End Date: September 2010 Status: Recruiting Purpose: This is a randomized, double-blind, multi-centered study to compare six months of medical treatment with digoxin or propranolol in infants with SVT. Neither digoxin nor propranolol has been evaluated for pediatric use in a controlled trial in the context of SVT, yet both medications are used frequently. The specific aims of the study are to determine whether propranolol and digoxin differ in the: 1) Incidence of recurrent SVT in infants after six months of treatment with propranolol or digoxin; 2) Time to first recurrence of SVT in infants treated with propranolol or digoxin; and 3) Incidence of adverse outcomes in infants treated with propranolol or digoxin. Phase: III Contact: Karen Gibbs, RN, kgibbs@cw.bc.ca Title: Ablation of Inappropriate Sinus Tachycardia Syndrome by Targeting Cardiac Neural Input Number of Patients: 25 Trial Start Date: April 2004 Trial End Date: Estimated Study Completion Date: January 2010; Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure) Status: Recruiting Purpose: We hypothesize that radiofrequency ablation, targeting the sympathetic input of the sinus node identified by 20Hz stimulation in the right atrium and superior vena cava, will effectively reduce sinus rate acutely and reduce palpitations due to inappropriate sinus tachycardia without the need for pacemaker implantation due to sinus node dysfunction post ablation. Contact: Deborah J. Lockwood, MD, Principal Investigator, University of Oklahoma Health Sciences Center, deborah-lockwood@ouhsc.edu, Caroline Hilferink-Lenaerts, RN, MPH, CCRP, caroline-hilferink@ouhsc.edu Ventricular Fibrillation Title: An International, Randomized, Controlled Pre-hospital Trial of a Waveform-Based Automated External Defibrillation Algorithm for the Management of Ventricular Fibrillation Number of Patients: 1,000 Trial Start Date: May 2006 Trial End Date: April 2009 Purpose: This study is designed to examine the impact of an available technology within an automated external defibrillator (AED) to improve survival following out-of-hospital cardiac arrest for patients presenting in ventricular fibrillation. Contact: John P. Freese, MD, Principal Investigator, New York City Fire Department, Dawn Jorgenson, PhD, Study Director, Philips Medical Systems. Title: IN-TIME: Influence of Home Monitoring on the Clinical Status of Heart Failure Patients With an Impaired Left Ventricular Function Number of Patients: 620 Trial Start Date: July 2007 Trial End Date: Estimated Study Completion Date: July 2010; Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure) Status: Recruiting Purpose: Re-hospitalizations or deaths by worsening heart failure are often preceded by distinct trends of clinical parameters such as atrial or ventricular arrhythmia, activity, heart rate variability, or ventricular ectopy. The Home Monitoring capability offered by BIOTRONIK active implants has the potential to detect some of these trends early and thus offer the possibility to intervene in time for prevention of fatal worsening of heart failure. To investigate the predictive value of Home Monitoring parameters, patients with symptomatic heart failure and reduced ejection fractions receiving an implantable cardioverter-defibrillator (ICD) or an ICD in combination with cardiac resynchronization therapy (CRT-D) will be randomized between prospective patient management by Home Monitoring analysis or standard care. The influence of Home Monitoring on the clinical status of heart failure patients will be assessed using the Packer score, a combined endpoint of death, hospitalization, NYHA class and global self assessment. Phase: IV Contact: Heinrich Moertel, PhD, heinrich.moertel@biotronik.com For more information, please visit: http://clinicaltrials.gov/