Heart Failure Clinical Trials

Open to Enrollment

Study Identifier: PARAGLIDE
Principal Investigator: James Lyons, MD

Study Title: Safety and Tolerability of In-hospital Initiation of LCZ696 Compared to Valsartan in HFpEF Patients With Acute Decompensated Heart Failure (ADHF) Who Have Been Stabilized During Hospitalization (PARAGLIDE-HF)

Study Summary: The purpose of this study is to assess the effect of in-hospital initiation of sacubitril/valsartan (LCZ696) vs. valsartan on time averaged proportional change in NT-proBNP in patients with HFpEF (left ventricular ejection fraction (LVEF) > 40%) who have been stabilized during hospitalization for acute decompensated heart failure.

Study Identifier: The CARILLON Trial
Principal Investigator: Rajeev Narayan, MD

Study Title: The CARILLON Trial - Assessment of the Carillon® Mitral Contour System® in Treating Functional Mitral Regurgitation Associated With Heart Failure

Study Summary: The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the CARILLON Mitral Contour System in treating subjects with functional mitral regurgitation (FMR) associated with heart failure, compared to a randomized Control group which is medically managed according to heart failure guidelines. 

Study Identifier: National Cardiogenic Shock Initiative (NCSI) 
Principal Investigator: Simon Gorwara, MD

Study Title: National Cardiogenic Shock Initiative

Study Summary: This study evaluates the use of early mechanical circulatory support in patients presenting with acute myocardial infarction and cardiogenic shock. Patients are treated according to the National Cardiogenic Shock Initiative protocol, which emphasizes early identification of cardiogenic shock and rapid delivery of mechanical circulatory support based on invasive hemodynamics. All patients treated in this manner are enrolled in the National Cardiogenic Shock registry.

Study Identifier: GUIDE HF 
Principal Investigator: James Lyons, MD

Study Title: Hemodynamic-GUIDEd Management of Heart Failure (GUIDE-HF)

Study Summary: The GUIDE-HF IDE clinical trial is intended to demonstrate the effectiveness of the CardioMEMS™ HF System in an expanded patient population including heart failure (HF) patients outside of the present indication, but at risk for future HF events or mortality. 

Closed to Enrollment 

Study Identifier: CardioMEMS HF
Site Principal Investigator: James Lyons, MD

Study Title: CardioMEMSTM HF System Post Approval Study

Study Summary: The purpose of this Post Approval Study (PAS) is to evaluate the use of the FDA approved CardioMEMS HF System in patients with Class III Heart Failure in a commercial setting. The CardioMEMS HF system is not investigational and would be recommended by your cardiologist as standard of care to treat your heart failure if your symptoms meet the guidelines for its use. The CardioMEMS Heart failure (HF) monitoring system has been shown to significantly reduce HF hospital admissions and improve quality of life in NYHA class III patients. Heart failure (HF) is a clinical syndrome characterized by frequent hospitalization, poor quality of life, multiple comorbidities, high mortality and a complex therapeutic regimen.