Florida Region

1-888-TENET4U

5810 Coral Ridge Drive, Suite 300 Coral Springs, Florida 33076

Cardiovascular Clinical Trials

CARDIOVASCULAR CLINICAL TRIALS

GLORIA-AF

  • Global Registry on Long-Term Oral Antithrombotic Treatment in Patient with Atrial Fibrillation (Phase II-III)
  • The Principal investigator is Dr. Craig Vogel.
  • The Sponsor is Boehringer Ingelheim.
  • The Study will take place at Tenet Florida Heart and Cardiovascular Network in Jupiter.

ORBIT AF

  • Phase II of the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF II) is designed to evaluate the utilization of target-specific antithrombotic agents, such as factor Xa (FXa) inhibitors and direct thrombin inhibitors, and associated outcomes. Importantly, the ORBIT-AF II registry will permit the collection and analysis of post-approval observational data needed for evaluating the outcomes associated with these new agents when used in broader patient populations outside of clinical studies. The ORBIT-AF II registry will focus on patients with newly diagnosed atrial fibrillation (AF) as well as those who have been
  • recently started on a target-specific oral anticoagulant agent.
  • The Principal Investigator is Dr. Craig Vogel
  • The Clinical Coordinator is Miriam Johnson
  • The Sponsor is Duke Clinical Research Institute (DCRI) and Janssen Scientific Affairs, LLC (JSA)
  • The Study will take place at Tenet Florida Heat and Cardiovascular Network in Jupiter.

REVEAL

  • REVEAL(Randomized EValuation of the Effects of Anacetrapib through Lipid-modification): A large-scale, randomized placebo-controlled trial of the clinical effects of anacetrapib among people with established vascular disease. Large-scale randomized trials have shown that lowering LDL cholesterol by about 1 mmol/L for 4-5 years reduces the risks of coronary events and of strokes by about one fifth. Furthermore, recent trials assessing more intensive versus standard statin regimens have demonstrated additional benefit with more intensive lowering of LDL cholesterol. Nevertheless, among individuals with a history of vascular disease or diabetes, cardiovascular risk remains elevated even after several years of intensive LDL-lowering treatment.
  • The Principal Investigator is Dr. Craig Vogel.
  • The Clinical Coordinator is Miraim Johnson.
  • The Sponsor is The Brigham and Women's Hospital, Inc.
  • The Study will take place at Tenet Florida Heart and Cardiovascular Network in Jupiter.

ODYSSEY

  • A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of SAR236553/REGN727 on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome. The primary objective of this study is to compare the effect of SAR236553 with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in patients who have experienced an acute coronary syndrome (ACS) event 4 to 16 weeks prior to randomization and are treated with intensive statin therapy (defined as atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) or at maximally tolerated dose of these given statins, or other non statin LMT(s).
  • The Principal Investigator is Dr. Rahul Aggarwal.
  • The Clinical Coordinator is Cristina Baroni.
  • The Sponsor is SANOFI.
  • The Study will take place at Tenet Florida Heart and Cardiovascular Network in Jupiter.

CIRT

  • The primary aim of the Cardiovascular Inflammation Reduction Trial (CIRT) is to directly test the inflammatory hypothesis of atherothrombosis by evaluating whether or not low-dose methotrexate (LDM) will reduce rates of myocardial infarction, stroke, and cardiovascular death among stable coronary artery disease patients with type 2 diabetes or metabolic syndrome, conditions associated with an enhanced pro-inflammatory response. CIRT is a randomized, double-blind, placebo-controlled, multi-center, event-driven trial that will randomize 7,000 men and women from the United States and Canada.
  • The Principal Investigator is Dr. Craig Vogel.
  • The Clinical Coordinator is Miriam Johnson.
  • The Sponsor is Brigham and Women's Hospital.
  • The Study will take place at Tenet Florida Heart and Cardiovascular Network in Jupiter.

AGUSTUS - AF

  • 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 Principal Investigator is Dr. Rahul Aggarwal.
  • The Clinical Coordinator is Cristina Baroni.
  • The Sponsor is Bristol Mayers, Inc.
  • The Study will take place at Tenet Florida Heart and Cardiovascular Network in Jupiter.

COMMANDER-HF

  • A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Rivaroxaban with Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects with Heart Failure and Significant Coronary Artery Disease Following an Episode of Decompensated Heart Failure.
  • The Principal Investigator is Dr. Craig Vogel.
  • The Clinical Coordinator is Miriam Johnson.
  • The Sponsor is Janssen Research & Development.
  • The Study will take place at Tenet Florida Heart and Cardiovascular Network in Jupiter.

TENDYNE

  • Tendyne Bioprosthetic Mitral Valve System. The purpose of this expanded clinical study is to evaluate the performance and safety of the Tendyne Mitral Valve System in the treatment of severe mitral regurgitation in patents with functional disability greater than or equal to NYHA Class II, who are not suitable candidates for surgical replacement with otherwise available devices. The data gathered in this study may be used to support conformity requirements for CE Mark of the Tendyne system.
  • The Principal Investigators are Dr. Brijeshwar Maini and Brian Bethea.
  • The Clinical Coordinator is Wanda Trabal.
  • The Sponsor is Tendyne Holdings, Inc.
  • The Study will take place at Delray Medical Center.

SURTAVI

  • Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI). Medtronic CoreValve™ System and CoreValve™ Evolut™ R System. The purpose of this trial is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI.
  • The Principal Investigator is Dr. Brijeshwar Maini.
  • The Clinical Coordinator is Christine DaCosta.
  • The Sponsor is Medtronic.
  • The Study will take place at Delray Medical Center.

REPRISE III

  • REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus™ Valve System – Randomized Clinical Evaluation. Objective is to evaluate the safety and effectiveness of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical valve replacement.
  • The Principal Investigator is Dr. Brijeshwar Maini.
  • The Clinical Coordinator is Christine DaCosta.
  • The Sponsor is Boston Scientific Corporation.
  • The Study will take place at Delray Medical Center.

SHIELD II

  • Assess the safety and efficacy of the HeartMate PHP in supporting patients with severe symptomatic coronary artery disease with diminished but stable cardiovascular function, who are undergoing elective or urgent high risk percutaneous coronary interventions (PCI) but are not candidates for coronary artery bypass graft (CABG) surgery.
  • The Principal Investigators are Dr. Brijeshwar Maini and Dr. Brian Bethea.
  • The Clinical Coordinator is Christine DaCosta.
  • The Sponsor is Thoratec Corporation.
  • The Study will take place at Delray Medical Center.

PARACHUTE

  • Percutaneous Ventricular Restoration in Chronic Heart Failure due to Ischemic Heart Disease. The primary objective of Phase I is to demonstrate the reasonable assurance of safety of the CKI Parachute implant in the subjects with NYHA Class III or IV (AMBULATORY) heart failure due to ischemic heart disease at 30 days. The primary objective of the combined Phase I & II is to evaluate the reasonable assurance of safety and effectiveness of the CKI Parachute implant in the treatment of subjects with NYHA Class III or IV (AMBULATORY) heart failure due to ischemic heart disease.
  • The Principal Investigators are Dr. Brijeshwar Maini and Dr. Brian Bethea.
  • The Clinical Coordinator is Christine DaCosta.
  • The Sponsor is CardioKinetix, Inc.
  • The Study will take place at Delray Medical Center.

EVOLUT R - LOW RISK

  • Transcatheter Aortic Valve Replacement (TAVR) in Patients with the Medtronic Transcatheter Aortic Valve Replacement System (TAVR) in Patients at Low Risk for Surgical Aortic Valve Replacement (SAVR). Evaluate and Demonstrate the safety and effectiveness of the Medtronic TAVR System in patients, 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 with severe aortic stenosis at low risk for SAVR.
  • The Principal Investigator is Dr. Brijeshwar Maini.
  • The Clinical Coordinator is Christine DaCosta.
  • The Sponsor is Medtronic.
  • The Study will take place at Delray Medical Center.

GLOBAL CVAD REGISTRY

  • The goal of the Global cVAD Registry is to collect clinical and procedural data retrospectively from hospital medical records for patients who received one or multiple lmpella devices in routine clinical care, across all participating sites without pre­ selection.
  • The Principal Investigator is Dr. Brijeshwar Maini.
  • The Clinical Coordinator is Christine DaCosta.
  • The Sponsor is Abiomed, Inc.
  • The Study will take place at Delray Medical Center.

ABSORB IV

  • THE ABSORB III RANDOMIZED CONTROLLED TRIAL. ABSORB III Primary Objective: The pivotal trial to support the US pre-market approval (PMA) of Absorb BVS. ABSORB III will evaluate the safety and effectiveness of the Absorb BVS System compared to the XIENCE in the treatment of subjects, including those with diabetes mellitus, with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.
  • The Principal Investigator is Dr. Agusto Villa.
  • The Clinical Coordinator is Elizabeth Wettermann.
  • The Sponsor is Abbott Vascular.
  • The Study will take place at Palm Beach Gardens Medical Center.

INFRAREDX- LIPID-RICH PLAQUE

  • The Lipid-rich Plaque Study will determine the relationship in patients undergoing IVUS-NIRS (near- infrared spectroscopy) imaging between lipid-rich plaque detected by intracoronary NIRS at non- stenotic sites and subsequent coronary events from new culprit lesions at both the patient level (vulnerable patients) and the segment level (vulnerable plaques).
  • The Principal Investigators are Dr. Agustus Villa, Dr. Miguel Diaz & Dr. Robert Cardia.
  • The Clinical Coordinator is Elizabeth Wettermann, Rafael Diaz & Christine DaCosta.
  • The Study will take place at Palm Beach Medical Center, Delray Medical Center & Palmetto General Hospital.

Stay Connected

Join us on Facebook

Watch us on YouTube

Follow us on Twitter