Clinical Trials

Clinical Trials

A complete list of clinical trials run by the Division of Cardiovascular Medicine can be found in the 2014 Department of Medicine annual report, here.

ELECTROPHYSIOLOGY CLINICAL TRIALS:

  • AdaptResponse -  The purpose of this study is to see if receiving electrical treatment from a chronic resynchronization therapy device (CRT) device with the aCRT programming feature is better than receiving electrical treatment from a CRT device with the standard method of CRT device programming. PI: Kenneth Bilchick, MD  Status: open to enrollment

  • Efficacy and Safety of Intranasal MSP-2017 for the Conversion of Induced Paroxysmal Supraventricular Tachycardia to Sinus Rhythm - The purpose of this study is to demonstrate the superiority of at least 1 dose of intranasal (IN) MSP-2017 over placebo in terminating supraventricular tachycardia (SVT) induced in an electrophysiology (EP) laboratory. PI: Kenneth Bilchick, MD    Status: open to enrollment

  • LAPTOP – Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study: The purpose of this trial is to evaluate the safety and clinical effectiveness of the left atrial pressure monitoring system linked with a physician-directed, patient self-management therapeutic strategy to limit left atrial pressure excursions in ambulatory patients with advanced heart failure, with a control group receiving optimal medical therapy in a prospective randomized multicenter trial. PI: John Ferguson   Status: closed to enrollment

  • Micra Transcatheter Pacing Study: A prospective, multi-site, single-arm, worldwide Investigational Device Exemption clinical study to evaluate the safety and efficacy of the Micra Transcatheter Pacing system and to assess long-term device performance. PI: John Ferguson  Status: open to enrollment

  • MultiSENSE - The purpose of this study is to gather information from currently implanted cardiac resynchronization therapy defibrillators (CRT-D) that are modified with investigational software to determine ability in predicting heart failure events. PI: Andrew Darby, MD     Status: closed to enrollment

  • RAID- Late Sodium Current Blockade in High-Risk ICD Patients Ranolazine ICD Trial: The purpose of this trial is to determine whether ranolazine (Ranexa) administration will decrease the likelihood of a composite arrhythmia endpoint consisting of VT/VF requiring antitachycardia pacing, ICD shocks, or death. PI: John DiMarco  Status: closed to enrollment

  • REFINE ICD – The purpose of this study is to test whether an implantable cardioverter -defibrillator (ICD) versus medical management can increase the likelihood of survival in patients at risk of heart rhythm irregularities, as determined from a 24-hour heart monitor that is performed within 2-15 months after a heart attack.  Status: open to enrollment

     

  • SCORE  - The purpose of this study is to collect information about the long term performance of the St. Jude Medical cardiac rhythm management (CRM) devices. PI: Kenneth Bilchick, MD  Status: open to enrollment

  • S-ICD Post-Approval Study: The purpose of this trial is to evaluate the long-term performance of the subcutaneous implantable cardioverter- defibrillator (ICD) system. PI: Pamela Mason, MD   Status: open to enrollment

  • SJ4 Post Approval Study: The purpose of this study is to evaluate the long term performance of the St. Jude Medical right ventricular lead used with St. Jude Medical cardiac resynchronization therapy defibrillator (CRT-D) or implantable cardioverter- defibrillator (ICD) devices.. PI: Kenneth Bilchick