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Device

Device for Heart Failure (HOPE4HF Trial)

N/A
Waitlist Available
Led By William Abraham, MD
Research Sponsored by CVRx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

HOPE4HF Trial 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).

HOPE4HF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Heart failure metric improvements from baseline
System and procedure related adverse events

HOPE4HF Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DeviceExperimental Treatment2 Interventions
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.
Group II: Medical ManagementActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

CVRx, Inc.Lead Sponsor
20 Previous Clinical Trials
8,740 Total Patients Enrolled
11 Trials studying Heart Failure
7,461 Patients Enrolled for Heart Failure
Michael Zile, MDStudy ChairMedical University of South Carolina
4 Previous Clinical Trials
1,659 Total Patients Enrolled
4 Trials studying Heart Failure
1,659 Patients Enrolled for Heart Failure
William Abraham, MDPrincipal InvestigatorOhio State University
10 Previous Clinical Trials
5,046 Total Patients Enrolled
8 Trials studying Heart Failure
4,986 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
BAROSTIM® Hope for Heart Failure Study
2012. "BAROSTIM® Hope for Heart Failure Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01720160.
All > Heart Failure With Preserved Ejection Fraction
~8 spots leftby Apr 2025
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