Clinical Trials at Gill

• BIO LIBRA (Biotronik) Electrophysiology
• BIO-AffectDX
• OPTIMIZER Electrophysiology
• RELIEVE-HF Heart Failure
• REVERSE-IT General Cardiology
• MK-5475-007
• WARRIOR (Department of Defense) Women's Cardiology

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OPTIMIZER SMART POST-APPROVAL STUDY

PI: Aaron Hesselson, MD

Coordinator: Ben Rushing 859-323-5259

Objective: To evaluates data such as cardiac outcomes, quality of life, mortality, and functionality. Long term data are also needed to assess complication rates and potential interactions with other implantable devices in the intended patient population. The post-approval study (PAS) protocol has been designed to address these concerns in a real-world setting.

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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.

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BIO-AffectDX- Atrial Fibrillation associated with Heart Failure treated by BIOTRONIK’s CRT-DX System

PI: Aaron Hesselson, MD

Coordinator: Ben Rushing 859-323-5259

Objective: To evaluate the percent of all subjects with improvement from baseline in heart failure patients with paroxysmal, persistent, and long-standing persistent AF subtypes implanted with a two-lead BIOTRONIK CRT-DX system.

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LEADLES-II

PI: Aaron Hesselson, MD

Coordinator: Ben Rushing 859-323-5259

Objective: To confirm the safety and effectiveness of the Aveir device from implant through 6-weeks in a subject population indicated for a VVI(R) pacemaker.

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EMPACT-MI

PI: John Kotter, MD

Coordinator: Stephanie Morris 859-323-5366

Objective: To demonstrate the superiority of empagliflozin 10 mg once daily versus placebo, in addition to standard of care, for the reduction of the composite endpoint of time to first heart failure hospitalization or all-cause mortality in high-risk patients hospitalized for acute MI.

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

PI: Vincent L. Sorrell, MD

Coordinator: Ben Rushing, 859-323-5259

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.

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RELIEVE-HF TRIAL: REducing Lung congestIon symptoms using the v-wavE shunt in adVancEd Heart Failure

PI: John Gurley, MD

Coordinator: Stephanie Morris 859-323-5366

Objective: To provide reasonable assurance of safety and effectiveness of the V-Wave Interatrial Shunt System by improving meaningful clinical outcomes in patients with NYHA functional class II, class III or ambulatory class IV heart failure, irrespective of left ventricular ejection fraction, who at baseline are treated with guideline-directed drug and device therapies.

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REVERSE-IT: A Phase 3, Multicenter, Open-Label, Single-Arm Study of PB2452 in Ticagrelor-Treated Patients with Uncontrolled Major or Life-Threatening Bleeding or Requiring Urgent Surgery or Invasive Procedure

PI: Ahmed Abdel-Latif, MD, PhD

Coordinator: Jennifer Isaacs 859-323-4738

Objective: To demonstrate reversal of the antiplatelet effects of ticagrelor with IV infusion of PB2452 and to demonstrate the clinical efficacy of PB2452 by assessment of hemostasis in ticagrelor-treated patients with uncontrolled major or life-threatening bleeding or who are undergoing urgent surgery or invasive procedure in a an open-label, single-cohort study.

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MK-5475-007: A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults with Pulmonary Arterial Hypertension

PI: David Booth, MD

Coordinator: Stephanie Morris 859-323-5366

Objective: Two cohorts to evaluate the effect of MK-5475

• versus placebo on the pulmonary vascular resistance (PVR) at Week 12
• versus placebo on 6-minute walk distance (6MWD) at Week 12

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

PI: Gretchen Wells, MD, PhD

Coordinator: Evan Cassity, 859-218-6633

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.

John Kotter, 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

Research Coordinators

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

Travis Sexton, PhD
Phone: 859-323-1082
Email: Trsesxt2@uky.edu

The division supports a clinical trial section, led by John Kotter, 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.