Research and Clinical Trials
 
 

Research and Clinical Trials

BayCare facilities currently participate in a multitude of clinical research for heart and vascular care. For more information on any of these trials, please contact the participating facility.

Below are the open trials and the current participating facilities*:

Advanced Structural Heart and Valve

  • Medtronic Transcatheter Aortic Valve Replacement in Low Risk Patients

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR.

Participating facility: Morton Plant Hospital

  • PORTICO IDE/Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial 

The PORTICO clinical trial is a prospective, multi-center, randomized, controlled clinical study, designed to evaluate the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico) via transfemoral and alternative delivery methods.

Participating facility: Morton Plant Hospital

  • TENDYNE Transcatheter Mitral Valve Replacement 

The purpose of this study is to generate initial insights into the safety and performance of the Tendyne Mitral Valve System. The study includes adult patients with symptomatic mitral regurgitation who are not suitable candidates for conventional mitral valve repair or replacement.

Participating facility: Morton Plant Hospital

Arrhythmia

  • AdaptResponse

This study is a prospective, randomized, controlled, interventional, single-blinded, multi-center, post-market, global Cardiac Resynchronization Therapy (CRT) in heart failure (HF) clinical study. The purpose of this clinical study is to test the hypothesis that market released CRT devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal AV conduction and left bundle branch block (LBBB).

Participating facilities: Morton Plant Hospital and Mease Countryside Hospital

  • Augustus: An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients with Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention

The purpose of this study is to determine if apixaban is noninferior to Coumadin (INR target range of 2.0-3.0) on the combined endpoint of major and relevant non-major bleeding in patients with non-valvular AF who develop acute coronary syndrome and/or require PCI with planned concomitant P2Y12 inhibitor therapy and to determine if anticoagulant plus single antiplatelet therapy with a P2Y12 inhibitor is superior to anticoagulant plus dual antiplatelet therapy with a P2Y12 inhibitor and aspirin on the combined outcome of ISTH major bleeding and clinically relevant non-major bleeding in patients with non-valvular AF who develop ACS and/or undergo PCI with concomitant anticoagulant.

Participating facility: BayCare Medical Group Cardiology

  • Product Surveillance Registry 

The purpose of this study is to provide continuing evaluation and periodic reporting of the safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support the interests of patients, hospitals, clinicians, regulatory bodies, payers and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

Participating facility: St. Joseph’s Hospital

Percutaneous Coronary Intervention

  • A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia (STRENGTH)

The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.

Participating facility: BayCare Medical Group Cardiology (North Bay)

  • ABLATE/Atherectomy By Laser Ablation With Turbo-Elite 

The primary objective for this study is to prove the safety and effectiveness of the Spectranetics Turbo-Elite catheter in atherectomy treatment for infrainguinal arteries with catheter to vessel sizing of at least 50 percent.

Participating facility: Winter Haven Hospital

  • ABSORB IV/Absorb IV Randomized Controlled Trial

ABSORB IV is a prospective, randomized (1:1, Absorb BVS to XIENCE), single-blind, multi-center study, registering approximately 3000 subjects at approximately 140 sites. ABSORB IV is a continuation of ABSORB III (NCT01751906) trial which are maintained under one protocol because both trial designs are related. The data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.

Participating facility: Morton Plant Hospital

  • ARTEMIS/Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study 

The ARTEMIS trial is a practical multicenter, cluster- randomized clinical trial that will assess the impact of copayment reduction by equalizing the copayment of clopidogrel and ticagrelor. ARTEMIS will assess prescribing patterns, patient medication adherence, and clinical outcomes up to one year. We hypothesize that reducing out-of-pocket cost for P2Y12 receptor inhibitor will lead to improved adherence. Additionally, copayment reduction of both generic and brand antiplatelet agents may lead to a reduction in MACE risk. This is in part due to greater adherence to an evidence—based secondary prevention medication. Additionally the reduction in MACE may reflect greater selection of a more potent antiplatelet agent that has been shown to reduce MACE in randomized clinical trials, as provider choice of antiplatelet therapy will be primarily driven by risk benefit assessment rather than the cost burden to the patient.

Participating facilities: Morton Plant Hospital, Winter Haven Hospital and St. Joseph’s Hospital

  • Athersys NSTEMI

A Phase 2 Trial of AMI Multistem® Therapy in Subjects With Non-ST Elevation Acute Myocaridal Infarction (MI-MSTEMI)

This is a double-blind, sham-controlled clinical study to evaluate the safety and feasibility of AMI MultiStem therapy in subjects who have had a heart attack (Non-ST elevation MI).

Participating facilities: Morton Plant Hospital

  • RE-DUAL PCI 

The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg Dabigatran Etexilate Dual Antithrombotic Therapy (DE-DAT)) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus ASA <= 100mg q.d. (warfarin-TAT) in patients with atrial fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome (ACS)). The study aims to show noninferiority of both doses of DE-DAT when compared to Warfarin-TAT in efficacy and safety. Efficacy will be determined by comparing a composite death and thrombotic event rate of death, myocardial infarction, stroke and systemic embolism. In addition, comparisons will be made of the rates of clinically relevant bleeding, assessed using the modified International Society of Thrombosis and Haemostasis (ISTH) major classification.

Participating facility: Winter Haven Hospital

  • BTK Trial

A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Drug Coated Balloon Versus Standard Balloon Angioplasty for Treatment of Below-the-Knee (BTK) Arteries (Lutonix BTK Trial)

The purpose of this Phase 2 study is 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.

Participating facilities: Morton Plant Hospital and Mease Countryside Hospital

  • STOP-PAD

A Phase 2B Randomized Double Blind Placebo Controlled Study to Evaluate the Safety and Efficacy of JVS-100 Administered by Direct Intramuscular Injection as Adjunct to Revascularization of Infrapopliteal Lesions in Subjects With Advanced Peripheral Artery Disease and Tissue Loss

The purpose of this study is to investigate the efficacy of the administration of JVS-100 delivered via direct intramuscular injections on a 3 month and 6 month composite endpoint of wound progression, healing and limb loss in patients with severe peripheral arterial disease with non-healing chronic wounds who undergo an open bypass grafting or endovascular procedure for treatment of infrapopliteal disease and are dosed within 2 days and 3 months following the procedure.

Participating facility: Morton Plant Hospital

Heart Failure

  • PIONEER-HF

The purpose of this study is to assess the effect of in-hospital initiation of sacubitril/valsartan (LCZ696) vs. enalapril on time averaged proportional change in NT-proBNP in patients who have been stabilized following hospitalization for acute decompensated heart failure (ADHF) and reduced ejection fraction (left ventricular ejection fraction (LVEF) ≤ 40%).

Participating facility: Winter Haven Hospital

  • DREAM-HF/TEVA C41750/3100 Study

A Double-blind, Randomized, Sham-Procedure controlled, Parallel-group Efficacy and Safety Study of allogenic Mesenchymal Precursor Cells (CEP-41750) in Patients with Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology

The primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived MPCs (CEP-41750) is effective in the treatment of chronic heart failure due to LV systolic dysfunction.

Participating facility: Morton Plant Hospital

*Research and clinical trials as of 08/08/17