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

  • ACURATE IDE Transcatheter Replacement of Stenotic Aortic through Implantation of ACURATE in Subjects Indicated for TAVR

The study objective is to evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.

Participating facility: Morton Plant Hospital

  • Medtronic OPTIMIZE PRO TAVR Post Market Study 

The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an “optimized” TAVR care pathway and using the EvolutTM PRO and EvolutTM PRO+ devices.

Participating facility: Morton Plant Hospital

  • Clinical TRIal to EvaLUate Cardiovascular OutcoMes IN PAtients Treated with the Tricuspid ValvE Repair System Pivotal (TRILUMINATE Pivotal) 

The objective of this trial is to evaluate the safety and effectiveness of the TriClipTM device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR) who have been determined by the site’s local heart team to be at intermediate or greater estimated risk for mortality with tricuspid valve surgery. 

Participating facility: Morton Plant Hospital 

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

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

  • SUMMIT Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation  

The objective of this trial is to evaluate the safety and effectiveness of the Tendyne Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification. 

Participating facility: Morton Plant Hospital

Arrhythmia/Heart Rhythm 

  • 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

  • BIO-LIBRA Study AnaLysIs of Both Sex and Device Specific FactoRs on Outcomes in PAtients with Non-Ischemic Cardiomyopathy

This multi-center, observational study is designed to prospectively assess outcomes of device-treated ventricular tachyarrhythmias and all-cause mortality in non-ischemic cardiomyopathy patients indicated for ICD or CRT-D implantation for the primary prevention of sudden cardiac death. Differences in outcomes will be evaluated by sex and by device type.

Participating facilities: Morton Plant Hospital and Mease Countryside Hospital

  • ECG Belt for CRT Response (ECG Belt)

The purpose is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling. The ECG Belt Research System will be used at implant and follow-up to help implanters choose a suitable LV pacing site within the recommended locations for LV lead implantation and optimize pacing vector/timing parameters in line with the EHRA/HRS 2012 expert consensus statement. The first 6 months of follow-up will focus on using the ECG Belt Research System to help choose pacing site, vector and post-implant follow-up pacing programming. From 6 to 9 months the ECG Belt Research System will be used to further investigate more personalized programming at follow-up visits

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

  • Ultrasensitive Electroanatomic Mapping to Adjudicate Endpoints for Ablation in Paroxysmal AF Patients Using Cryoballon

The primary objective is to retrospectively analyze electroanatomic maps to determine endpoints that confer acute procedural success and long term arrhythmia free survival in patients with paroxysmal atrial fibrillation undergoing pulmonary vein isolation using cryoballoon. 

Participating facility: 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 

  • RELIEVE HF: REducing Lung congestIon symptoms using the v-wavE shunt in adVancEd Heart Failure

This is a prospective, multi-center, 1:1 randomized, patient and observer blinded clinical study, with a Shunt Treatment arm and a non-implant Control arm. A total of approximately 400 patients will be randomized. Patients will be blinded during follow up for a minimum of 12 months to a maximum of 24 months. Control patients will have the opportunity to receive a shunt once unblinded, if they provide consent and continue to meet inclusion/exclusion criteria. All implanted patients will be followed for a total of five years from the time of the study device implantation.

Participating facility: Morton Plant Hospital

  • GUIDE-HF

This clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF system in patients with New York Heart Association (NYHA) class II, III, or IV heart failure (HF) who have an elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) (or an elevated brain natriuretic peptide (BNP)) and/or a prior HF hospitalization (HFH). This clinical trial will be conducted under an investigational device exemption (IDE) and is intended to support an expanded indication for the CardioMEMS HF system. This clinical trial is sponsored by Abbott.

Participating facility: Morton Plant Hospital 

  • National Cardiogenic Shock Initiative (NCSI)

The aim of the NCSI is to bring together experienced centers across the nation that are experts in mechanical reperfusion therapies and have a large experience with the use of mechanical circulatory support devices to systematize care in AMICS. Our goal is to dramatically decrease the duration patients remain in cardiogenic shock and attempt to decrease total usage and duration of vasopressors and ionotropic agents. We aim to further demonstrate that rapid delivery of mechanical circulatory support will improve hemodynamics, reverse the spiraling neuro-hormonal cascade associated with cardiogenic shock, allowing clinicians to decrease use of vasopressors and inotropic agents and ultimately improve survival. Health care systems that have agreed to adopt the NCSI treatment algorithm are being asked to participate in this prospective registry so that patient outcomes can be analyzed. Participating investigators will be asked to voluntarily provide data from patients completing the treatment algorithm to be included in the NCSI Registry.

Participating facility: Morton Plant Hospital

  • EMPULSE - A multicentre, randomised, double-blind, 90-day superiority trial to evaluate the effect on clinical benefit, safety and tolerability of once daily oral EMPagliflozin 10 mg compared to placebo, initiated in patients hospitalised for acUte heart faiLure (de novo or decompensated chronic HF) who have been StabilisEd

The main objective of this study is to assess whether in-hospital administration of empagliflozin results in improvement in HF-related outcomes (clinical benefit including death, heart failure events (HFE) and the burden of symptoms as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score) in patients hospitalised for acute heart failure (de novo or decompensated chronic HF) and after initial stabilisation. Secondary objectives are to further assess whether it is safe to start empagliflozin in patients admitted to hospital in this setting.

Participating facility: Winter Haven Hospital

Coronary Artery Disease

  • Women’s Ischemia Trial to Reduce Events in Non-Obstructive CAD (WARRIOR) 

This study is being conducted to determine whether aggressive medication treatment to modify risk factors in women with coronary arteries showing no severe obstruction but with cardiac symptoms (i.e., chest pain) will reduce their likelihood of dying, having a heart attack, stroke or being hospitalized. The results of this study will provide the data necessary to inform future guidelines regarding how best to treat this growing population of women, and ultimately improve their cardiac health and quality of life and reduce health-care costs.

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

  • ASTELLAS A Phase 2 Proof of Concept, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury following Coronary Artery Bypass Graft (CABG) and/or Valve Surgery 

To evaluate the efficacy, safety and tolerability of postsurgery treatment with ASP1128 in subjects at risk for acute kidney injury (AKI) following coronary artery bypass graft (CABG) and/or valve surgery

Participating facility: Morton Plant Hospital 

  • cvMOBIUS - The Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 Inhibitors

Primary objective is to evaluate the real-world effectiveness of PCSK9is to reduce cardiovascular events in routine practice in a prospective cohort of adults presenting with a recent ASCVD event and/or revascularization procedure.

Participating facility: Mease Countryside Hospital

*Research and clinical trials as of 09/28/20