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 (Evolut Trial)

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

  • Medtronic BICUSPID Low-Risk Study 

Transcatheter aortic valve replacement (TAVR) with Medronic TAVR system in patients with severe bicuspid aortic valve stenosis and at low-predicted risk of mortality with surgical aortic valve replacement (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

  • REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects

To evaluate safety and effectiveness of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Sets for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe aortic stenosis who are considered at intermediate risk for surgical valve replacement including those who have a bicuspid native valve.

Participating facility: Morton Plant Hospital

Arrhythmia 

  • 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

Percutaneous Coronary Intervention

  • XIENCE 28 Study

The objective of this trial is to evaluate safety of 28-day dual antiplatelet therapy (DAPT) in subject at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with XIENCE.

Participating facilities: Mease Countryside HospitalMorton Plant Hospital and Morton Plant North Bay Hospital

  • XIENCE 90 Study

The objective of this trial is to evaluate safety of three-month dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with XIENCE.

Participating facilities: Mease Countryside HospitalMorton Plant Hospital and Morton Plant North Bay 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

  • Emperor Reduced and Preserved EF Trials

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

Participating facility: Mease Countryside 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 facilities: 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 facilities: Morton Plant Hospital 

*Research and clinical trials as of 08/16/19