BAROSTIM® Hope for Heart Failure Study | NCT01720160 | Trialant

BAROSTIM® Hope for Heart Failure Study | NCT01720160 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Device	Experimental	1) BAROSTIM NEO System and 2) standard of care medical management therapy for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.	Device: BAROSTIM NEO® System Other: Standard of care medical managment therapy for heart failure
Medical Management	Active Comparator	Standard of care medical management therapy for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.	Other: Standard of care medical managment therapy for heart failure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Heart failure metric improvements from baseline	To describe changes in measures compared to baseline.	12 months
System and procedure related adverse events	To demonstrate the safety of the Neo system in a heart failure population.	6 months

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Michael Zile, MD	Medical University of South Carolina	Study Chair
William Abraham, MD	Ohio State University	Principal Investigator
Fred Weaver, MD	University of Southern California	Principal Investigator
Faiez Zannad, MD	Inserm Centre d'Investigation, CHU de Nancy	Principal Investigator
JoAnn Lindenfield, MD	Vanderbilt Heart and Vascular Institute	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25982108	Result	Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-496. doi: 10.1016/j.jchf.2015.02.006. Epub 2015 May 14.
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