Heart and Vascular Clinical Trials

Let's fight heart disease together

Clinical trials are research studies that evaluate new drugs or treatment strategies and determine if they are effective. Each clinical trial is designed to find a new or better way to treat common, and complex, heart and vascular issues.

We have a large number of short- and long-term clinical trials underway involving the use of new pharmacotherapeutic agents or new therapeutic strategies for the treatment of the following:

Aortic Aneurysms

  • RelayBranch System 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. Contact: 352.273.7598
  • RelayPro® Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers This study investigates the safety and effectiveness of the RelayPro® Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms and penetrating atherosclerotic ulcers of the descending thoracic aorta. Contact: 352.273.7598
  • Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)Primary Study Arm TAAA requiring only TAMBE System. Crawford Type IV TAAASecondary Study Arm TAAA requiring TAMBE System and CTAG Device(s). Crawford Type I-IIIContact: 352.273.7598


Aortic Dissection


Aortic Stenosis

  • EARLY TAVR

    This trial is for the evaluation of transcatheter aortic valve replacement (TAVR) compared to surveillance for patients with asymptomatic severe aortic stenosis. Patients are randomized to receive either 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.

Atrial Fibrillation

  • DEEP Pivotal Study – Add to Atrial Fibrillation section
    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, ablation catheters.

Coronary Artery Disease

  • GE Aurora
    This trial is for patients that are undergoing testing for coronary artery disease. The purpose of this study is to see how well a new liquid imaging tracer called Flurpiridaz (F-18), which contains a very small dose of radioactivity, can detect Coronary Artery Disease (CAD) during a PET (positron emission tomography) scan. We will compare images of your heart taken from a procedure called a SPECT (single photon emission computed tomography) scan. We will then compare the SPECT scan images to a Flurpiridaz (F-18) injected PET scan procedure of your heart. The PET scan images using Flurpiridaz (F-18) will also be compared with the results of your cardiac catheterization. These comparisons will help us test how accurate PET scan images are when used with Flurpiridaz (F-18).Contact: 352.273.7598

Critical Limb Ischemia

  • ACP-01 in Patients With Critical Limb Ischemia
    Injection of ACP-01, comprised of blood-derived autologous ACPs, in subjects with critical limb ischemia who are receiving standard of care therapy and have no endovascular or surgical revascularization options.Contact: 352.273.7598
  • Electrophysiology (ECG Belt)
    This is a trial for patients being implanted with a Medtronic BiV ICD or BiV PM device. The purpose of this study is to compare the management of patients using the ECG Belt Research System to routine hospital practice. The Medtronic ECG Belt Research System will be used at some or all of your study visits. If the ECG Belt Research System is used during the implant procedure, it may help to guide where the left heart wire (lead) is placed. If the ECG Belt Research System is used during follow-up visits, it may help with adjusting the settings.


Heart Attack

  • MI-NSTEMI
    This trial is evaluating the effect of donor stem cells on heart function over time in patients who have had a heart attack.
    Contact: 352.273.8933
  • MiRNA 
    This trial is for patients who are having a heart attack. This study is being conducted because researchers are trying to recreate a miniature version of the heart on an electronic chip using stem cells. This is called a “heart-on-a-chip,” and if successful, it may help researchers discover new molecules that can help detect heart disease. 
    Contact: 352.273.8933
  • AEGIS II 
    This trial is for patients who have just had a heart attack. The purpose of this study is to find out how effective and safe CSL112, a mixture of ApoA-I from donated human blood and fats derived from soybeans, is at reducing the risk of dying from heart-related events such as having another heart attack or having a stroke. CSL112 resembles high density lipoprotein, which is sometimes better known as the ‘good cholesterol.’
    Contact: 352.273.8933

Heart Disease in Women

  • HARP
    This is an observational trial for women who present to the hospital for a heart attack and do not have obstructive coronary artery disease after undergoing cardiac catheterization. This trial is using various cardiac imaging techniques to improve understanding about plaque and coronary artery disease in women.
    Contact: 352.273.8933
  • Warrior
    This trial is for women who have signs and symptoms of ischemia and no obstructive coronary disease to evaluate intensive medical therapy compared to usual care. It targets clinically stable women with angina or equivalent symptoms of sufficient severity to seek, or have sought, referral for coronary angiography or coronary CT angiogram within the previous 2 years. This trial will evaluate intensive medical therapy compared with usual care and targets active duty, veterans and military dependent women.

    Contact: 352.273.8933


Heart Failure

  • CardiAMP™ Heart FailureThis is a trial to evaluate the effect of stem cell therapy using donor’s concentrated bone marrow compared to sham control patients. The trial is for patients who have heart failure (ejection fraction <20% - <40%) as a result of a heart attack.
    Contact: 352.273.8933

  • Cytokines 
    This is a trial for patients with heart failure with low and normal ejection fractions. This study will collect and measure markers in your blood that tell us about the levels of inflammation in your blood. The information collected from this study will be used in future studies to explore other heart failure therapy treatment in heart failure patients. 

  • Invested 
    This is a trial for patients who have had a heart attack or a heart failure hospitalization. The purpose of this study is to see if an investigational high-dose influenza (“flu”) vaccine is able to safely reduce heart or lung-related problems compared with the standard-dose flu vaccine. 

  • Momentum 3
    This trial studies the safety and effectiveness of the HeartMate 3 Left Ventricular Assist System (LVAS) by demonstrating non-inferiority to the HeartMate II Left Ventricular Assist System when used for the treatment of advanced, refractory, left ventricular heart failure.

    Contact: 352.273.7837

 

Heart Valve Disease

  • PROACT XaA prospective, randomized, active (warfarin) controlled, parallel-arm clinical trial to determine if participants with an On-X® aortic valve can be maintained safely and effectively on the factor Xa inhibitor apixaban. This is a prospective, multicenter, open-label, randomized active controlled clinical trial to determine if apixaban is non-inferior to warfarin (INR target range 2.0 - 3.0) in participants with an On-X mechanical heart valve implanted in the aortic position. Each participant will be followed for at least 2 years.

Hypertension

  • Minocycline Patients diagnosed with uncontrolled hypertension who have not been able to achieve good blood pressure control after treatment with three blood pressure medications may be eligible to participate in this study. The purpose is to observe the effects of low and high doses of the drug minocycline in patients with drug-resistant hypertension.Contact: 352.273.8933

Microvascular Dysfunction

  • WISE HFpEF 
    This trial is for women who have signs and symptoms of ischemia and no obstructive coronary disease. The purpose of this trial is to examine small vessel disease (a condition in which the small arteries in the heart become narrowed). We want to know how the small vessel disease contributes to pre-HFpEF (a condition with inadequate heart muscle function in the setting of preserved muscle pumping) and to better identify potential treatment for prevention of HFpEF.