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Clinical Trials at Gill

The UK Gill Heart & Vascular Institute Cardiology Clinical Research Center is designed to facilitate all aspects of patient-based clinical research. This includes coordination of Phase 1-4 multicenter drug and device trials, investigator-initiated protocols and translational studies. Multidisciplinary collaborations within the Gill and across UK HealthCare are key to our successful patient enrollment. Avid support of the infrastructure for clinical trials as well as education of faculty, fellows and Gill staff in clinical research methodology is at the core of our continued success.

Since its inception, the Gill Heart & Vascular Institute Cardiology Clinical Research Center has been at the forefront in leading multicenter trials investigating novel devices for patent foramen ovale (PFO) closure and left atrial pressure monitoring to treat heart failure as well as novel drug therapy for acute coronary syndrome (ACS), post-stent (post PCI) treatment, and atrial fibrillation.

The Gill offers innovative, leading-edge cardiac care including stem cell regenerative medicine for advanced heart failure, novel lipid lowering therapy and the latest catheter-based interventions.

  • Currently enrolling clinical trials

    • BIO LIBRA (Biotronik) Electrophysiology
    • QP ExCELS (Biotronik) Electrophysiology
    • OPUS Registry (Actelion) Pulmonary Hypertension
    • PRECISE (HeartFlow, Inc.) General Cardiology
    • PFO PAS (Abbott) Structural Cardiology
    • COMPASSION S3 (Edwards Lifesciences) Structural Cardiology
    • KNOCOUT PE (EKOS Corporation) Interventional Cardiology
    • WARRIOR (Department of Defense) Women's Cardiology

    BIO LIBRA - AnaLysIs of Both Sex and Device Specific FactoRs on Outcomes in PAtients with Non-Ischemic Cardiomyopathy

    PI: Aaron Hesselson, MD

    Coordinator: Ben Rushing 859-323-5259

    Objective: To evaluate the combined risk of all-cause mortality and treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events by subject sex and by implanted device type. All-cause mortality, VT or VF alone, risk of cardiac death, and sudden cardiac death will be analyzed for the total cohort, as well as by subject sex and by the implanted device type.
     

    Sentus QP – Extended CRT Evaluation with quadripolar left ventricular leads) EP PASSION/MPP Sub-Study Amendment (QP ExCELs)

    PI: Aaron Hesselson, MD

    Coordinator: Ben Rushing, 859-323-5259

    Objective: Clinical study intended to confirm the safety and efficacy of the Sentus QP leads to support regulatory approval, as well as to demonstrate that the MPP feature is effective by converting a percentage of cardiac resynchronization therapy (CRT) non-responders to responders.

    OPsumit USers Registry (OPUS)

    PI: David Booth, MD

    Coordinator: Chris Webb, 859-323-1082

    Objective: This study is a prospective observational drug registry developed to further characterize the safety profile (including primarily potential serious hepatic risks) and to describe clinical characteristics and outcomes of patients newly treated with Opsumit in the post-marketing setting.

    The PRECISE Protocol: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization (PRECISE)

    PI: Vincent L. Sorrell, MD

    Coordinator: Chris Webb, 859-323-1082

    Objective: To assess clinical outcomes, decision making regarding noninvasive testing and invasive angiography, and costs using a precision evaluation strategy as compared to a usual care strategy in participants with stable symptoms suggestive of significant coronary artery disease. The precision evaluation strategy will be based on a pre-test risk assessment and will incorporate cCTA with selective FFRCT and guideline-recommended care with symptom and risk factor management and no immediately planned testing.

    AMPLATZER PFO Occluder Post Approval Study (PFO PAS)

    PI: John Gurley, MD

    Coordinator: Stephanie Morris, 859-323-5366

    Objective: Clinical study intended to demonstrate the safety and effectiveness of the AMPLATZER PFO Occluder, in a post-approval setting, in patients with a PFO who have had a cryptogenic stroke.

    COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

    PI: Andrew Leventhal, MD, PhD

    Coordinator: Jennifer Isaacs, 859-323-4738

    Objective: To determine safety and efficacy of the Edwards Sapien 3 Transcatheter Heart Valve System in patients with dysfunctional right ventricular outflow tract with clinical indication for intervention.

    An International Pulmonary Embolism Registry Using EKOS (KNOCOUT PE)

    PI: Adrian Messerli, MD

    Coordinator: Travis Sexton, 859-323-3617

    Objective: This registry is designed to understand acoustic pulse thrombolysis (APT) treatment regimens used as standard of care globally for pulmonary embolism. The registry will include individuals who have already received the APT treatment and those that will undergo APT treatment.

    Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD (WARRIOR)

    PI: Gretchen Wells, MD, PhD

    Coordinator: Denise Sparks, RN, 859-218-6713

    Objective: To determine whether intensive medication treatment to modify risk factors and vascular function in women patients with coronary arteries showing no flow limit obstruction but with cardiac symptoms (i.e., chest pain, shortness of breath) will reduce the patient's likelihood of dying, having a heart attack, stroke/TIA or being hospitalized for cardiac reasons. The results will provide evidence data necessary to inform future guidelines regarding how best to treat this growing population of patients, and ultimately improve the patient's cardiac health and quality of life and reduce health-care costs.

  • Clinical research team

    Khaled Ziada, MD
    Director, Gill Heart & Vascular Institute Cardiology Research Center

    Jennifer Isaacs, MS, MS, CCRP
    Clinical Research Administrative Director
    Cardiovascular and Radiology Services
    Gill Heart & Vascular Institute Clinical Research Organization
    Phone: 859-323-4738
    Fax: 859-257-7383
    Email: jennifer.isaacs@uky.edu

    Stephanie Morris, CCRP
    Clinical Research Operations Manager – Cardiovascular and Radiology Services
    Gill Heart & Vascular Institute Clinical Research Organization
    Phone: 859-323-5366
    Fax: 859-257-7383
    Email: stephanie.a.morris@uky.edu

    Melanie Elam
    Regulatory Coordinator - Cardiovascular and Radiology Services
    Gill Heart & Vascular Institute Clinical Research Organization
    Phone: 859-323-8658
    Fax: 859-257-7383
    Email: mgelam2@uky.edu

    Research Coordinators

    Rebekah Evans, RN, BSN, CCRP
    Phone: 859-323-8663
    Email: rebekah.evans@uky.edu

    Chris Webb, MS, MS, RN
    Phone: 859-323-1082
    Email: christopher.webb1@uky.edu

    Ben Rushing, CCRC
    Phone: 859-323-5259
    Email: ben.rushing@uky.edu

    The division supports a clinical trial section, led by Khaled Ziada, MD, and Clinical Research Director Jennifer Isaacs, MS, MS, CCRP. Phase 1-4 drug and device clinical trials across a multitude of areas including structural heart disease, coronary artery disease, heart failure and electrophysiology are currently in progress.

    The strength of our clinical research efforts, particularly regarding innovative catheter-based approaches to heart and vascular disease, is unmatched. We conduct leading-edge cardiovascular treatment approaches including renal denervation, left atrial pressure monitoring for heart failure, resorbable coronary stents and stem cell regenerative medicine. Historically, we have been a top enroller in multicenter trials investigating novel devices for PFO closure, left atrial pressure monitoring (to treat heart failure) and ASD closure as well as novel drugs for treatment of ACS and the prevention of secondary coronary events.

    Our strength and commitment to clinical trial research increases the accessibility of state-of-the-art treatments to patients across Kentucky that would otherwise not exist in this region of the country. The University of Kentucky’s Center for Clinical and Translational Science (CCTS) awarded by the National Institutes of Health places the university in an elite group of 60 biomedical research institutions poised to solve the toughest challenges in medicine and surgery using innovative approaches.