At The Cardiac & Vascular Institute Research Foundation, we believe that today’s clinical trials provide the foundation for tomorrow’s clinical practice. Since its establishment in 2010, TCAVIRF has been at the forefront of cardiovascular research. We participate in both cardiac and peripheral arterial disease clinical trials that are patient focused and provide access to important new drugs and devices that help improve quality of life and survival in patients with cardiovascular disease.

As a leader of research and development, we are proud to currently offer a variety of research trials, including those listed below.

To learn more about our research trials, please contact The Cardiac & Vascular Institute Research Foundation at (352) 244-0208, option 5.

Available Studies

Atrial Fibrillation

ARTESIA (enrolling)

The purpose of the study is to determine which treatment, apixaban or aspirin, is best for preventing stroke or systemic embolism in patients who have > 1 episode of sub-clinical atrial fibrillation (SCAF) detected by pacemaker or ICD or ICM and also have other risk factors for stroke.

Gloria-AF (follow-up)

The primary objectives of this registry is to

  • Characterize patients newly diagnosed with non-valvular AF at risk for stroke on a global level
  • Study patterns, predictors and outcomes of different treatment regimens for stroke prevention in non-valvular AF
  • Collect data on the safety and effectiveness of antithrombotic treatments, such as the long time standard of care VKA, and novel oral anticoagulants such as dabigatran etexilate.

Coronary Artery Disease

Dal-GenE (enrolling)

The double-blind, randomized, placebo-controlled, multicenter Phase 3 clinical trial will enroll 5,000 patients recently hospitalized with ACS and who express the AA genotype at variant rs1967309 in the ADCY9 gene, determined by an investigational companion diagnostic test developed by Roche Molecular Systems (RMS). The primary endpoint of the study is the time to first occurrence of any component of the composite of cardiovascular death, myocardial infarction (heart attack) and stroke. The trial will be conducted at 1,000 sites in 33 countries.

ECLIPSE (enrolling)

The purpose of this trial is to evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES). This is a prospective, randomized one to one (1:1), multi-center trial designed to evaluate vessel preparation with Orbital Atherectomy (OA) compared to conventional balloon angioplasty technique prior to stent implantation for the treatment of severely calcified coronary artery lesions.

EVOLVE Short DAPT (follow-up)

The primary objective of the EVOLVE Short DAPT Study is to assess the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk for bleeding undergoing percutaneous coronary intervention (PCI) with the SYNERGY Stent System.

Ilumien IV (enrolling)

The objective of this clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions.

ONYX bifurcation (enrolling)

To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.

To collect data on the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in bifurcated lesions.

National Cardiogenic Shock Initiative (NCSI) (enrolling)

This study evaluates the use of early mechanical circulatory support in patients presenting with acute myocardial infarction and cardiogenic shock. Patients are treated according to the National Cardiogenic Shock Initiative protocol, which emphasizes early identification of cardiogenic shock and rapid delivery of mechanical circulatory support based on invasive hemodynamics. All patients treated in this manner are enrolled in the National Cardiogenic Shock registry.

SAFE STEMI for seniors (enrolling)

Patients with partially blocked blood vessel(s) in their heart may need a medical procedure called “Percutaneous Coronary Intervention (PCI)” to open the narrowed blood vessel(s). The purpose of this study is to simultaneously address four potential advances in ST-Elevation Myocardial Infarction (STEMI) care for patients at least 65 years old. The investigators are looking to see if these advances can improve the outcome for these patients.

  1. Opening the arteries with a Medtronic stent
  2. Radial access (from wrist) success with a Medtronic stent
  3. Checking the percent of blockage in the diseased artery/arteries using Volcano guide wires.
  4. Reduced bleeding and vascular complications with radial arterial access for primary PCI in STEMI

XIENCE 90 (enrolling)

XIENCE 90 study is a prospective, single arm, multi-center, open label trial to evaluate the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with the approved XIENCE family of coronary drug-eluting stents.

Heart Failure

CardioMEMS PAS (follow-up)

The purpose of the CardioMEMS HF System Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with NYHA class III heart failure in a commercial setting. The objective of this PAS is to confirm safety and effectiveness in a commercial setting.

APPRAISE ATP (follow-up)

A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. Subject enrollment may begin in the hospital and will continue following release from the hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (4-12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

ADAPT Response (enrolling)

The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB).

Hypertension

CONTROL HTN-2 (enrolling)

To evaluate the safety and effectiveness of the ROX Coupler used to create an arteriovenous anastomosis in the iliac region (between the iliac artery and vein) in subjects with hypertension.

RADIANCE-HTN (enrolling)

RADIANCE-HTN is a randomized, double-blind, sham controlled, 2-cohort study (TRIO and SOLO) designed to demonstrate efficacy and document the safety of the Paradise Renal Denervation System in two distinct populations of hypertensive subjects.

See if you qualify:http://highbptrial.com/

Peripheral Artery Disease

 

Zilver PTX (follow-up)

The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral Stent in treatment of narrowing of the femoropopliteal arteries.

Chocolate Touch (enrolling)

The Chocolate Touch study is a randomized, multi-center, prospective, adaptive study, designed to show sufficient safety and effectiveness of the Chocolate Touch™ for use in superficial femoral or popliteal arteries with the intention of obtaining regulatory approval to market this device in the United States.

 

Levant BTK (follow-up)

To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.

ILLUMENATE (follow-up)

This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with peripheral arterial disease.

 

Other

WRAP-IT (follow-up)

The World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded, post-market, interventional clinical study will evaluate the effectiveness of the TYRX(TM) Absorbable Antibacterial Envelope in reducing major infections in patients with cardiac implantable electronic devices (CIEDs) at risk for infection.

LSS-4-Site (follow-up)

The goal of the study is to evaluate, document and report on the appropriate clinical performance, long-term reliability and the functional integrity of the Boston Scientific ENDOTAK RELIANCE® 4-SITE™ Lead and the pulse generator 4-SITE Header.