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Research & Clinical Trials

Active Research Studies

The Dr. Kiran C. Patel Research Institute oversees dozens of research studies every year across many clinical disciplines. Patients that are admitted to our hospitals who meet specific criteria for studies may be asked to participate in a research study, but are never obligated to.

If you are interested in participating in one of our trials, you will need to complete a Release of Information form.

Following is a list of research studies that are currently active at our hospitals.


ABLATE: AF Registry Trial (AtriCure Synergy Bipolar RF Energy Lesions for Non-paroxysmal Forms of Atrial Fibrillation Treatment During Concomitant On-Pump Endo/Epicardial Cardiac Surgery)
ABLATE AF is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating non-paroxysmal forms of atrial fibrillation.
Lead Coordinator: Cynthia Paysor


ABSORBE RCT: Evaluation of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) System Abbott Stent Study A Clinical Evaluation of Absorb BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions (Abbott)
To evaluate the applicability and transferability of the didactic Absorb BVS physician training plan to US clinical practice. A non-randomized, single-arm, open label group assignment of subjects treated with Absorb BVS. The Lead-In Phase will enroll/register subjects prior to the randomization phase of ABSORB RCT. ABSORB III will evaluate the safety and effectiveness of the Absorb BVS system compared to the XIENCE in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary lesions in separate vessels.
Lead Coordinator: Beth Posey


ATHENA – Safety and Feasibility Trial of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia
This is a prospective, randomized, placebo-controlled, double blind safety and feasibility clinical trial. The purpose is to assess the safety and feasibility of Adipose-Derived Regenerative Cells (ADRCs) delivered via an intramyocardial route in the treatment of chronic ischemic heart disease in patients who are not eligible for percutaneous or surgical revascularization.
Lead Coordinator: Brian Nordgren


ATTRACT: Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis
The purpose of this study is to determine if the use of adjunctive Pharmacomechanical Catheter Directed Thrombolysis, which includes the intrathrombus administration of rt-PA--Activase (Alteplase), can prevent the post-thrombotic syndrome (PTS) in patients with symptomatic proximal deep vein thrombosis (DVT) as compared with optimal standard DVT therapy alone.
Lead Coordinator: Juliet Bala


AWARE AKI M13-796 A Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for thePrevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery: Acute Kidney Prevention
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Cardiac Surgery
Lead Coordinator: Yvonne Gopsill


CANTOS: (Novartis) Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)
A Phase 3, a randomized, double-blind, placebo-controlled, event-driven trial of quarterly subcutaneous canukinumab (a fully human monoclonal antibody for treatment of inflammatory disease) in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP. A secondary hypothesis, that canakinumab treatment in patients with MI and pre-diabetes, will prevent new onset diabetes will also be tested. The study will continue until 694 cardiovascular endpoints are accrued in approximately 7,302 randomized patients.
Lead Coordinator: Cynthia Paysor


EVITA: Evaluation of Varenicline (Champix) in Smoking Cessation for Patients Post-Acute Coronary Syndrome
In patients who have suffered a heart attack Varenicline has been recently shown to increase the number of otherwise healthy people who quit smoking compared to placebo (sugar pill). Although varenicline has been shown to reduce smoking in healthy populations, its effectiveness in patients recovering from a heart attack is unknown. The EVITA trial will help answer this question.
Lead Coordinator: Diane Bashton


MASTER II - INSPIRE MD MGuard™ Prime Stent System Clinical Trial in Patients With Acute ST Elevation Myocardial Infarction
To evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of blocked arteries in coronary arteries in patients undergoing a stenting procedure due to having a heart attack. The MGuard Prime stent wil be compared to other FDA approved bare-metal (BMS) or drug-eluting (DES) coronary stents. The hypotheses are that (1) the MGuard Prime stent will achieve a higher rate of complete ST-segment resolution as seen on the post-procedure ECG as compared to the comparator stent, and will have a similar effect on the rate of all-cause death or recurrent target vessel myocardial infarction at 365 days post-procedure.
Lead Coordinator: Shannon Harrison


ODYSSEY: Evaluation of Cardiovascular Outcomes after an Acute Coronary Syndrome during Treatment with SAR236553 (REGN727) (ODYSSEY Outcomes)
To compare the effect of SAR236553 (REGN727) with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in patients who have experienced an acute coronary syndrome (ACS) event 4 to 16 weeks prior to randomization and are treated with evidence-based medical and dietary management of dyslipidemia.
Lead Coordinator: Cynthia Paysor


OPEN: Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System
This self-expanding stent (FlexStent®) is designed specifically to cope with the extreme demands of the superficial femoral artery (SFA)/proximal popliteal artery. The intent of this study is to demonstrate that the FlexStent® Femoropopliteal Self-Expanding Stent System is safe and effective for the treatment of patients with peripheral arterial disease.
Lead Coordinator: Diane Bashton


PARACHUTE IV  (Percutaneous Ventricular Restoration in Chronic Heart Failure due to Ischemic Heart DiseasE)  A Pivotal Trial to Establish Efficacy and Long Term Safety of the Parachute Implant System
A Prospective, Multicenter, Randomized, Controlled, Pivotal Trial of the CardioKinetix Parachute Implant. CardioKinetix has developed a catheter-based treatment for patients with left ventricular dilation after an anterior MI. The implantable device, called the Parachute Implant, is a partitioning membrane deployed within the compromised ventricle. The Parachute Implant Isolates the dysfunctional region of the ventricle and decreases functional chamber volume treatment of ischemic heart failure.
Lead Coordinator: Cynthia Paysor


PHYSICIAN WELLNESS STUDY
The purpose is to evaluate the feasibility of a convenient health screening program for physicians. Evaluate if physician perceptions of health status change over time. The benefits will be having the knowledge about your health that may prompt follow-up care if indicated. Wellness education and coaching. Outcomes used to design future health screening programs for physicians.
Lead Coordinator: Peter Bath, D. Min, MBA


REGULATE: A Study To Determine the Efficacy and Safety of REG1 Compared to Bivalirudin in Patients Undergoing PCI
This study is designed to determine the efficacy of REG1 compared to bivalirudin in preventing periprocedural ischemic complications and major bleeding in patients undergoing PCI as a treatment for CAD. Bivalirudin has been studied in patients undergoing PCI in both ACS (NSTEMI and unstable angina [UA]) and elective PCI. In comparison to UFH, bivalirudin has shown similar rates of ischemic events while demonstrating a significant reduction in bleeding and an improved net clinical benefit.
Lead Coordinator: Shannon Harrison


SAPPHIRE: Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy
The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease in the high-risk population. The devices to be utilized are the Cordis PRECISE Nitinol Stent Systems (5.5F and 6F) and the Cordis ANGIOGUARD XP Emboli Capture Guidewire (ECGW).
Lead Coordinator: Betsy Szymanski


SILVER AMI
A research study of older persons who are admitted to the hospital with a heart attack. Patients will be interviewed in the hospital and again 6 months later. The researchers will also collect detailed medical record information to understand the effect of heart attacks on older persons. The research team at Yale University will use this information to develop a risk model that can be used to help doctors predict recovery. The goal of the study is to help older people in the future make well-informed decisions about their health care during a heart attack.
Lead Coordinator: Diane Bashton


ZILVER® Vena™ Venous Stent (VIVO EU)
This prospective, non-randomized, multi-center study is intended to evaluate the Zilver® Vena™ stent in the treatment of symptomatic iliofemoral venous outflow obstruction. It is a self-expanding, slotted-tube nitinol stent designed to improve luminal diameter in the ileofemoral veins for the treatment of venous outflow obstruction.
Lead Coordinator: Juliet Bala