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UVA Department of Medicine: FY 2015 Annual Report

Clinical Trials

Division of Cardiovascular Medicine
RESEARCH

Click here for Electrophysiology Clinical Trials

  • Exercise Capacity: Predictors of exercise capacity during stress exercise electrocardiography. (PI: Jamie Bourque, with Kevin Driver)
  • Lantheus 302: Assessment of myocardial perfusion using positron emission tomography (PET) imaging or flurpiridaz f18 injection in patients with known or suspected coronary heart disease (PI: Jamie Bourque)
  • MRI-CT: Prevalence and correlation of abnormal flow reserve by stress CMR and non-obstructive CAD by cardiac CT in symptomatic diabetics: what is the optimal risk satisfaction method? (PI: Jamie Bourque)
  • PET-LVH: Noninvasive detection of early metabolic remodeling in left ventricular hypertrophy. (PI: Jamie Bourque)
  • EXERRT (Astellas): Exercise to Regadenoson in Recovery Trial PI: Jamie Bourque
  • GE HEALTHCARE: An Open-Label, Multicenter, Phase 4 Study to Demonstrate the Prognostic Usefulness of Andreview Scintigraphy for Identifying Subjects with Heart Failure who will Experience Death during 60 months follow-up. (PI: Jamie Bourque)
  • Astellas Scientific and Medical Affairs, Inc. Assessment of Myocardial Flow Reserve and Effects of Exercise Training in Patients with Angina and Negative Coronary Angiograms. (PI: Jamie Bourque)
  • ACCELERATE: Assessment of clinical effects of cholesterylester transfer protein inhibition with Evacetrapib in patients at a high-risk for vascular outcomes. (PI: Lawrence Gimple)
  • Pegasus: A randomized, double-blind, placebo-controlled, parallel group, multinational trial to assess the prevention of thrombotic events with ticagrelor compared to placebo on a background of acetyl salicylic acid (ASA) therapy in patients with history of myocardial infarction. (PI: Lawrence Gimple)
  • Pharmaceutical Research Associates, Inc. OPUS Registry Opsumit (Macitentan) Users Registry. (PI: Jamie Kennedy)
  • CAP2: Continued access to PREVAIL-CAP2 – Watchman device in left atrial appendage for stroke prevention in AFIB patients. (PI: Scott Lim)
  • COAPT: Clinical outcomes assessment of the MitraClip percutaneous therapy for high surgical risk patients in functional mitral regurgitation patients. (PI: Scott Lim)
  • GORE-ASD: A study to evaluate safety and efficacy in the treatment of transcatheter closure of ostium secundum atrial septal defects using Gore septal occluder. Pediatric and adult patients. (PI: Scott Lim)
  • REALISM: A continued access registry of the Evalve MitraClip system – EVEREST II real-world expanded multicenter study of the MitraClip system. Patients with severe degenerative or functional mitral insufficiency undergo MitraClip implantation. (PI: Scott Lim)
  • Direct Flow Medical, Inc. SALUS – The Direct Flow Medical Transcatheter Aortic Valve Replacement System a US Pivotal Trial. (PI: Scott Lim)
  • Claret Medical, Inc. Claret Medical Sentinel IDE Study (PI: Scott Lim)
  • St. Jude Medical, Cardiology Division, Inc. Closure of A trial Septal Defects with the Amplatzer Septal Occluder (AS) Post Market Surveillance Study (PI: Scott Lim)
  • Bon Secours Richmond Health Care Foundation. Medtronic SURTAVI Study. (PI: Scott Lim)
  • EXCEL: Evaluation of XIENCE PRIME or XIENCE V versus coronary artery bypass surgery for effectiveness of left main revascularization. (PI: Michael Ragosta)
  • PreSERVE AMI: A prospective randomized double-blinded, placebo-controlled phase II trial of intra-coronary infusion of AMR001, a bone marrow-derived autologous CD34+ selected cell product in patients with acute myocardial infarction and low LVEF post STEMI. (PI: Michael Ragosta)
  • Resolute Integrity: A post-approval study of the Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System in the treatment of de novo lesions in native coronary arteries with a reference vessel diameter of 2.25mm to 4.2mm. (PI: Michael Ragosta)
  • Hamilton Health Sciences Corp. COMPLETE MI (PI: Michael Ragosta)
  • Inspire MD. MGuard Prime Stent System Clinical Trial in Patients with Acute ST Elevation Myocardial Infarction, IMD-10 (PI: Michael Ragosta).
  • Biotronik, Inc. BIOTRONIX-BIOF Clinical Protocol for the BIOFLOW-V study (PI: Michael Ragosta)
  • Leland Stanford Junior University. Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) 3 Trial. (PI: Michael Ragosta).
  • Cardiac Assist, Inc. CardiacAssist TandemHeart Theme Registry (PI: Michael Ragosta).
  • Corindus, Inc. CorPath Regional Preseptorship Agreement (PI: Michael Ragosta).
  • Biomet. MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia (CLI) in submects with Advance Peripheral Arterial Disease (PAD). (PI: Aditya Sharma)
  • Portola Pharmaceuticals, Inc. Multicenter, Randomized, Active-controlled efficacy and safety study comparing extended-duration betrizaban with standard of care enoxaparin for the prevention of venous thromboembolism in acute medically ill patients. (PI: Aditya Sharma).
  • GLORIA: Global registry on long-term oral anti-thrombotic treatment in patients with atrial fibrillation. (PI: Allan Simpson)
  • GORE REDUCE: Gore Helex Septal Occluder and antiplatelet medical management for reduction of recurrent stroke or imaging-confirmed TIA in patients with patent foramen ovale (PFO). (PI: Nina Solenski)

ELECTROPHYSIOLOGY CLINICAL TRIALS

  • CABANA – Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA) Trial: This is an NIH – National Heart Lung and Blood Institute study. There are 140 centers, inside US and elsewhere, participating. The purpose of this 5 year, global study is to compare drug therapy and catheter ablation in patients with atrial fibrillation (AF). This study will help decide which treatment approach is best or when one or the other therapy is preferred. The CABANA study will also compare the cost of care for the two treatment approaches and determine the effect these therapies have on quality of life. (PI: J. Michael Mangrum)
  • HANSEN Trial: A prospective randomized study of the Hansen System for introducing and positioning the ThermoCool® catheter in patients with atrial fibrillation. A multi-center, US and outside US (OUS), randomized study comparing remote vs. manual introduction and positioning of the Biosense ThermoCool catheter for mapping and ablation in patients with atrial fibrillation. The purpose is to demonstrate the safety and chronic procedural success rates for the Biosense ThermoCool catheter remotely introduced and positioned through the Artisan Guide Catheter to manual introduction and positioning of the ThermoCool Catheter. (PI: J. Michael Mangrum)
  • HEARTLIGHT Trial: Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System–AdaptiveContact(EAS-AC) or HEARTLIGHT for the Treatment of Symptomatic Atrial Fibrillation. A prospective, randomized, controlled study comparing an investigational technology called the EAS-AC to a standard treatment called radiofrequency (RF) ablation for the treatment of a heart rhythm abnormality called atrial fibrillation (AF). Up to twenty five hospitals are expected to be involved in the study. (PI: J. Michael Mangrum)
  • 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)
  • 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)
  • 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)
  • REFINE ICD – Risk Estimation Following Infarction Noninvasive Evaluation ICD Efficacy: The purpose of this trial is to assess whether prophylactic ICD therapy, guided by non-invasive risk assessment tools, reduces mortality in MI survivors with better-preserved LV function. PI: Rohit MalhotraS-ICD PAS- S-ICD System Post Approval Study: The purpose of this trial is to document long term safety and effectiveness outcomes with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in a commercial clinical setting. (PI: Pamela Mason)
  • SJ4 Post Approval Study: The purpose of this trial is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads. (PI: Kenneth Bilchick)
  • TOCCASTAR Trial: TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation. A prospective, randomized, multicenter, interventional study to evaluate the safety and effectiveness of the TactiCath® percutaneous ablation catheter for the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radiofrequency ablation. Patients will be enrolled at up to 30 sites in the United States (US) and elsewhere. (PI: J. Michael Mangrum)
  • VICTORY–AF Trial: Evaluation of Multielectrode Phased RF Technology in Persistent Atrial Fibrillation. A prospective global, multi-center, single-arm, investigational clinical study to be conducted at approximately 33 investigational sites. The purpose is to evaluate the risk of procedure- and/or device-related strokes in subjects with persistent or long-standing persistent atrial fibrillation undergoing ablation with the Phased RF System. (PI: J. Michael Mangrum)
  • ZERO Trial: Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation. A prospective, randomized, multi-center, controlled global investigation to establish the safety and effectiveness of the Blazer OI Catheter for the treatment of drug refractory symptomatic PAF. Patients will be enrolled at up to 33 sites in the United States (US) and elsewhere. (PI: J. Michael Mangrum)
  • TactiCath Quartz PAS Trial: An FDA post approval study. A prospective, non-randomized, multicenter, interventional study to evaluate the continued safety and effectiveness of the TactiCath Quartz Set for the treatment of symptomatic paroxysmal atrial fibrillation (PAF) using contact force assisted irrigated RF ablation. Patients undergoing elective catheter ablation for symptomatic PAF who are refractory or intolerant to at least one antiarrhythmic drug (AAD) (Class I-IV) will be enrolled. After the index procedure, subjects will be followed for a total of 60 months. The study will be conducted at up to 35 sites in the US. (PI: J. Michael Mangrum)
  • 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)
  • Micra Transcatheter Pacing System Study- The purpose of this study is to evaluate the safety and effectiveness of the Micra single chamber, leadless pacemaker and to assess its long-term performance. (PI: John Ferguson, MD)
  • Micra Transcatheter Pacing System Continued Access Study- The purpose of this study is to provide access to the Micra pacemaker and to continue to assess the safety and effectiveness of the Micra pacemaker during the FDA review process. (PI: John Ferguson, MD)
  • 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. (PI: Rohit Malhotra, MD)
  • S-ICD Post Approval Study- The purpose of this study is to evaluate the long-term performance of the subcutaneous implantable cardioverter- defibrillator (ICD) system. (PI: Pamela Mason, MD)
  • 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)
  • 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)
  • EMANATE- The purpose of this study is to compare the effectiveness of apixaban with usual care blood thinners in subjects with non-valvular AF who need cardioversion and blood thinners. (PI: John Ferguson, MD)
  • RAID- The purpose of the study is to see how effective a drug called ranolazine versus placebo is in reducing the risk of fast cardiac arrhythmias (irregular heart rhythm) and death in people with implantable cardioverter-defibrillators (ICDs). (PI: John DiMarco, MD, PhD)
  • LAPTOP- This study will collect information to manage heart failure using investigational systems called the Left Atrial Pressure (LAP) Monitoring Systems. (PI: John Ferguson, MD)
  • 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)
  • SJ4- 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, MD)
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