2020 UAB Cardiovascular Institute Annual Report CVI Annual Report 2019-2020 6

ISCHEMIC HEART DISEASE HEART FAILURE CARDIO-ONCOLOGY Trial: ECLIPSE PI: Arka Chatterjee, MD Brief Synopsis: Evaluation of treatment strategies for severe calcific coronary arteries: Orbital artherectomy vs conventional angioplasty technique prior to implantation of drug-eluting stents. Trial: PREEMPT-HF PI: William Maddox, MD Brief Synopsis: Precision event monitoring of patients with heart failure using HeartLogic. Trial: UPBEAT - Understanding and Predicting Breast Cancer Events after Treatment PI: Carrie G. Lenneman, MD Brief Synopsis: Women with breast cancer receive chemotherapy that can cause heart problems and related side effects, such as fatigue and exercise limitations. The purpose of this study is to compare these effects on people receiving chemotherapy for breast cancer compared to patients who do not have breast cancer. Trial: GE Aurora PI: Fadi Hage, MD Brief Synopsis: A phase 3, open-label, multicenter study of Flurpiridaz injection for positron emission tomography (PET) imaging for assessment of myocardial perfusion in patients referred for invasive coronary angiography because of suspected coronary artery disease. CARDIAC RHYTHM DISORDERS Trial: VISITAG SURPOINT PI: Tom McElderry, MD Brief Synopsis: Evaluation of the VISITAG SURPOINT module with external processing unit when used with the THERMOCOOL SMARTTOUCH SF and THERMOCOOL SMARTOUCH catheters for pulmonary vein isolation (PVI). Trial: Q-efficiency PI: Tom McElderry, MD Brief Synopsis: Evaluation of QDOT MICRO catheter for pulmonary vein isolation (PVI) in subjects with paroxysmal atrial fibrillation. VALVE DISEASE Trial: SUMMIT PI: Mustafa Ahmed, MD Brief Synopsis: A prospective, controlled, multicenter clinical investigation of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation. Trial: Triluminate PI: Mustafa Ahmed, MD Brief Synopsis: Clinical Trial to evaluate cardiovascular outcomes in patients treated with the tricuspid valve repair system. Trial: EARLY TAVR PI: James Davies, MD Brief Synopsis: Evaluation of transcatheter aortic valve replacement compared to surveillance for patients with asymptomatic severe aortic stenosis. 38 UAB Cardiovascular Institute Annual Report Trial: ANTHEM-HFrEF PI: Jose Tallaj, MD Brief Synopsis: Autonomic regulation therapy using the VITARIA system to enhance myocardial function and reduce progression of heart failure with reduced ejection fraction. Trial: GRAHF-2 PI: Sumanth Prabhu, MD Brief Synopsis: Validation of genetic sub-study from AHeFT that suggested a functional polymorphism of GNB3 impacts therapeutic efficacy of fixed dose isosorbide dinitrate/hydralazine in African American patients with HFrEF. PULMONARY VASCULAR DISEASE Trial: BREEZE PI: Robert Bourge, MD Brief Synopsis: An open-label, clinical study to evaluate the safety and tolerability of Trepostinil Inhalation Powder (TreT) in subjects with pulmonary arterial hypertension currently using Tyvaso. Trial: ADVANCE Outcomes PI: Jose Tallaj, MD Brief Synopsis: A phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background oral therapy in subjects with World Health Organization (WHO) Group 1 PAH. CARDIO-THORACIC SURGERY Trial: Quark PI: James Davies, MD Brief Synopsis: A randomized, double-blind, placebo- controlled, Phase 3 study to evaluate the efficacy and safety of QPI-1002 for the prevention of major adverse kidney events (MAKE) in subjects at high risk for acute kidney injury (AKI) following cardiac surgery. Trial: MIGHTY - Monitoring Immune Checkpoint Inhibitors for CardiToxicitY (MIghTY) PI: Carrie G. Lenneman, MD Brief Synopsis: Prospective study of cancer patients receiving immunotherapy to determine if specific risk factors predispose patients to developing cardiovascular events. VASCULAR SURGERY Trial: IDE Branch Fenestrated Endografts - IDE Trial PI: Adam Beck, MD TITLE: Evaluation of All-Cause Mortality and pulmonary Morbidity in treating Juxtarenal, Suprarenal and Thoracoabdominal Aortic Pathologies Using the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft and surgeon-Modified Endografts Description: Treatment of juxtarenal, suprarenal, and thoracoabdominal aortic pathologies (aneurysms, subacute or chronic dissections with aneurysmal degeneration, and penetrating aortic ulcers) involving at least one visceral artery that are not otherwise amenable to endovascular repair using a commercially available device. Trial: Cook 14-09 p-Branch PI: Adam Beck, MD TITLE: Zenith® p-Branch™ Pivotal Study (Pararenal or Juxtrarenal) Description: Endovascular treatment of patients with pararenal or juxtarenal AAA with morphology, renal fenestrations at same longitudinal level or the left renal fenestration lower longitudinally than right renal fenestration. Trial: GORE TBE SSB 11-02 - Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) PI: Adam Beck, MD TITLE: Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta Description: Endovascular treatment of thoracic aortic lesions which require coverage of the left subclavian artery, left common carotid artery, and/or the brachiocephalic trunk/innominate artery. Trial: STANCE - Statin Neuroprotection and Carotid Endarterectomy PI: Adam Beck, MD TITLE: Statin Neuroprotection and Carotid Endarterectomy: Safety, Feasibility, and Outcomes Description: An observational and randomized, placebo-controlled, clinical trial of statin dose maximization prior to carotid endarterectomy to protect against early cognitive dysfunction. CLINICAL TRIALS Trial: Relay PRO A - Continued Access PI: Benjamin Pearce, MD TITLE: A prospective, Multicenter, Non-Blinded, Non- Randomized Study of the Relay PRO Thoracic Stent- Graft in Subjects with Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers Description: Endovascular treatment of descending thoracic aortic aneurysms (TAA’s) and penetrating atherosclerotic ulcers (PAUs). Trial: GORE AAA 13-03 PI: Benjamin Pearce, MD TITLE: Assessment Of The GORE® Excluder® Conformable AAA Endoprosthesis In The Treatment Of Abdominal Aortic Aneurysms Description: Endovascular treatment of infrarenal AAA in patients with Short Neck (angulation ≤ 60˚ and infrarenal aortic neck length ≥ 10 mm) and in patients with highly angulated aortic necks (angulation > 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm). Trial: CALM-2 PI: Marc Passman, MD, with co-PI Suzanne Oparil, MD TITLE: Controlling and Lowering Blood Pressure with the MobiusHD Description: Patients with resistant hypertension who remain uncontrolled despite pharmacologic treatment with maximum tolerated, guideline-directed, anti- hypertensive pharmacologic therapy will be evaluated for randomization for the MobiusHD device vs. sham procedure. Trial: OSIRIS PI: Marc Passman, MD TITLE: A Multicenter, Prospective, Randomized, Open- Label Study with a Crossover Extension Option to Evaluate the Safety and Efficacy of GrafixPLTMPRIME for the Treatment of Chronic Venous Leg Ulcers Description: Patients who have been diagnosed as having a chronic venous leg ulcer (VLU) between 1 cm2 and 25 cm2, located below the knee and above the malleoli, > 4 weeks but not present for more than 52 weeks in subjects with venous insufficiency. uabmedicine.org 39

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