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

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 (enrolling)

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.

CIRT (follow-up)

The Cardiovascular Inflammation Reduction Trial (CIRT) is a randomized clinical trial investigating whether taking low-dose methotrexate reduces heart attacks, strokes, or death in people with type 2 diabetes or metabolic syndrome that have had a heart attack or multiple coronary blockages. This trial is funded by the National Heart, Lung, and Blood Institute (NHLBI)/National Institutes of Health (NIH).

PROMUS (follow-up)

This study is designed to observe clinical outcomes in patients receiving the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice. Patients will have symptomatic heart disease or documented silent ischemia. This is a prospective, open-label consecutively-enrolling study. Clinical follow-up is through 5 years. Approximately 2,689 patients are to be enrolled in up to 65 centers in the United States.

Heart Failure

CardioMEMS PAS (enrolling)

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 (enrolling)

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

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 (not enrolling)

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.

RANGER-BTK (enrolling)

The purpose of this study is to evaluate the safety and the efficacy of the Ranger™ SL paclitaxel coated balloon a model of drug eluting balloon in patients with critical limb ischemia.

Levant BTK (enrolling)

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.

Levant 2 Registry (follow-up)

The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries.

Levant 2 (follow-up)

The purpose of the study is to demonstrate the superior efficacy and non-inferior safety of the Moxy Drug Coated Balloon by direct comparison to standard percutaneous transluminal angioplasty (PTA) catheter for treatment of stenosis of the femoropopliteal arteries.

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.