ACCELERATE: Assessment of clinical effects of cholesterylester transfer protein inhibition with Evacetrapib in patients at a high-risk for vascular outcomes. (PI: Lawrence Gimple)
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)
EXCEL: Evaluation of XIENCE PRIME or XIENCE V versus coronary artery bypass surgery for effectiveness of left main revascularization. (PI: Michael Ragosta)
Exercise Capacity: Predictors of exercise capacity during stress exercise electrocardiography. (PI: Jamie Bourque, with Kevin Driver)
EXERRT (Astellas): Exercise to Regadenoson in Recovery Trial PI: Jamie Bourque
GLORIA: Global registry on long-term oral anti-thrombotic treatment in patients with atrial fibrillation. (PI: Allan Simpson)
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)
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)
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)
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)
PET-LVH: Noninvasive detection of early metabolic remodeling in left ventricular hypertrophy. (PI: Jamie Bourque)
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)
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)
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)
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
