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BAROSTIM® Hope for Heart Failure Study

NCT01720160 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2019-05-14

No results posted yet for this study

Summary

The purpose of this clinical investigation is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM® HOPE4HF Trial (NCT01720160).

Conditions

Interventions

DEVICE

BAROSTIM NEO® System

Implant procedure

OTHER

Standard of care medical managment therapy for heart failure

Standard of care medical management therapy for heart failure (AHA/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.

Sponsors & Collaborators

  • CVRx, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Zile, MD · Medical University of South Carolina

  • William Abraham, MD · Ohio State University

  • Fred Weaver, MD · University of Southern California

  • Faiez Zannad, MD · Inserm Centre d'Investigation, CHU de Nancy

  • JoAnn Lindenfield, MD · Vanderbilt Heart and Vascular Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-05-31
Completion
2021-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01720160 on ClinicalTrials.gov