Cardiovascular Surgery

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT)

Principal Investigator: Thomas Beaver, MD, MPH

Study Description: The objective of this trial is to evaluate the safety and effectiveness of the Tendyne Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification.


SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial (SMART)

Principal Investigator: George Arnaoutakis, MD

Study Description: The primary objectives of the trial are to demonstrate clinical non-inferiority and hemodynamic superiority of the Evolut PRO/PRO+ System when compared to subjects treated with the SAPIEN 3/3 Ultra System at 12 months post-procedure. Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE Transcatheter Aortic Valve (TAV) or an Edwards BE Transcatheter Heart Valve (THV). Both of these devices have already received FDA approval for use in aortic stenosis patients. Data will be collected at pre- and post-procedure, at discharge, at 30 days, and once a year until the 5-year follow-up is completed.


Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patients with Asymptomatic Severe Aortic Stenosis: EARLY-TAVR Trial

Principal Investigator: Thomas Beaver, MD, MPH

Study Description: : This trial is for patients with severe aortic valve stenosis that are not experiencing any valve related symptoms (i.e. shortness of breath, fatigue, dizziness).In this trial, patients are randomized to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 THV or clinical surveillance. Patients will be stratified by whether or not they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.


Pivotal Study of A Dual Epicardial & Endocardial Procedure (DEEP) Approach: DEEP Pivotal Trial

Principal Investigator: Thomas Beaver, MD, MPH

Study Description: The objective of this study is to establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation utilizing the AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System in an endoscopic or open ablation procedure, followed by an endocardial mapping and ablation procedure utilizing commercially available RF based, irrigated, power controlled, ablation catheters for endocardial lesions. The endocardial procedure will be staged to occur after 90 days post epicardial surgical procedure.


PROACT Xa – A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban

Principal Investigator: Thomas Beaver, MD, MPH 

Study Description: Currently, warfarin is the only approved anticoagulation for patients with mechanical valves. The purpose of this study is to determine if participants with an On-X Prosthetic Heart Valve / On-X aortic valve can be maintained safely and effectively on apixaban, a possible alternative to warfarin. Both the On-X aortic valve and apixaban have been approved for use by the US Food and Drug Administration (FDA) but they have not been approved to be used together.


Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury Following Coronary Artery Bypass Graft (CABG) and/or Valve Surgery

Principal Investigator: Thomas Beaver, MD, MPH

Study Description: The purpose of this study is to evaluate the efficacy of postsurgery treatment with ASP1128 in subjects at risk for acute kidney injury (AKI) following CABG and/or valve surgery.


Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery Patients (ReCePI)

Principal Investigator: Thomas Beaver, MD, MPH

Study Description: The objective of this study is to evaluate the efficacy and safety of RBC transfusion for support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment following transfusion of red blood cells (RBCs) treated with the INTERCEPT Blood System (IBS) for Red Blood Cells compared to patients transfused with conventional RBCs.


Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System (RelayBranch)

Principal Investigator: George Arnaoutakis, MD

Study Description: The purpose of this study is to conduct an early clinical evaluation of the Relay Branch System, which will provide initial insight into the clinical safety and function of the device. This Early Feasibility Study (EFS) will assess the safety and effectiveness of the device at the index procedure and at 30-day follow-up. The study will evaluate the delivery and deployment of the device, patency of branches and branch vessels, and exclusion of the aortic pathology. The data will help determine if modifications need to be made to the device, the procedural steps, operator technique, or the indications for use.



Please contact Jessica Cobb at 352.273.7837 or jessica.cobb@surgery.ufl.edu for more information about thoracic or cardiovascular surgery clinical trials.