Research and Clinical Trials
 
 

Research and Clinical Trials

Clinical research makes the latest scientific discoveries available to the BayCare community long before they become available to the general public. BayCare facilities currently participate in a multitude of clinical research for cardiovascular 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

  • Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitation – APOLLO Trial 

Multi-center, global, prospective, randomized, interventional, pre-market trial. Subjects will be randomized on 1:1 basis to either TMVR with the Medtronic Intrepid™ TMVR System or to conventional mitral valve surgery. Subjects ineligible for randomization may be enrolled through a single-arm trial. Subjects enrolled in the single-arm cohort will be assigned to TMVR with the Medtronic Intrepid™ TMVR System.

Participating facility: Morton Plant Hospital

  • A Randomized Evaluation of the TriGuard HDH Cerebral Embolic Protection Device and and the TriGUARD 3 Cerebral Embolic Protection Device to Reduce the Impact of Cerebral Embolic Lesions after Transcatheter Aortic Valve Implantation – The REFLECT Trial

Prospective, single-blind, three arm, randomized, (2 device: 1 control), multicenter safety and efficacy trial designed to enroll up to 533 total subjects in two consecutive phases: Phase I enrolled 258 subjects (including 54 roll-ins) and utilized TriGuard HDH and Phase II will enroll up to 275 subjects (including 40-50 roll-ins) and will utilize the TriGUARD 3.


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

  • 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 facilities: Morton Plant Hospital and Mease Countryside Hospital

  • Strategic Management to Optimize Response To Cardiac Resynchronization Therapy SMART CRT

This is a prospective, double-blind, multicenter, international, randomized controlled trial. The primary objective is to show the benefit of SmartDelay in patients with a prolonged RV-LV interval.

Participating facility: Winter Haven Hospital

• STOP AF First 

The purpose of the study is to provide data demonstrating the safety and effectiveness of the Arctic Front Advance™ Cardiac CryoAblation Catheter for the treatment of recurrent symptomatic paroxysmal AF, without the requirement that the subjects be drug refractory.

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

Percutaneous Coronary Intervention

  • 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 and St. Joseph’s Hospital

  • Eclipse

Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts: The ECLIPSE Trial. 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.

Participating facilities: St. Joseph’s Hospital

  • Reveal by Rex Revolution™ Peripheral Atherectomy System for Lower Extremity

Peripheral Arterial Revascularization (REVEAL). To evaluate the safety and effectiveness of the Revolution™ Peripheral Atherectomy System in the treatment of infrainguinal lower extremity peripheral arterial occlusive disease.

Participating facilities: St. Joseph’s Hospital

Heart Failure

  • CARDIAMP Heart Failure Trial

Randomized Controlled Pivotal Trial of Autologous Bone Marrow Cells Using the CardiAMP System in Patients with Post Myocardial Infarction Heart Failure.

Participating facilities: Morton Plant Hospital

  • CONNECT HF

This trial will be a large-scale, pragmatic, cluster-randomized clinical trial to evaluate the effect of two quality improvement (QI) initiatives compared with usual care on heart failure (HF) outcomes and HF quality of care metrics in the year following discharge for participants hospitalized with acute HF and reduced ejection fraction (EF).

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

  • Emperor

A phase III randomized, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with reduced Ejection Fraction (HFrEF) and in patients with preserved Ejection Fraction (HFpEF).

Participating facility: Mease Countryside Hospital

  • 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

  • VICTORIA

A Randomized Parallel-Group, Placebo-Controlled, Double-Blind, Event-Driven, Multi-Center Pivotal Phase III Clinical Outcome Trial of Efficacy and Safety of the Oral sGC Stimulator Vericiguat in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) - VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA).

Participating facilities: Mease Countryside Hospital, Morton Plant Hospital and St. Joseph’s Hospital 

*Research and clinical trials as of 08/17/18