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Device

Baroreflex Activation Therapy for Heart Failure (BeAT-HF 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
Currently NYHA Class II or III heart failure. For NYHA Class II, must have been NYHA Class III at any point in time within 3 calendar months prior to enrollment or at time of screening
The artery planned for the BAROSTIM implant must meet specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at study completion, approximately 5 years
Awards & highlights

BeAT-HF Trial Summary

This trialwill research a device to help treat heart failure. Subjects will be monitored for up to 5 years.

BeAT-HF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have been diagnosed with moderate to severe heart failure (NYHA Class II or III) within the past 3 months.
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The artery where the BAROSTIM implant will be placed must meet certain requirements.

BeAT-HF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at study completion, approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at study completion, approximately 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Amino-terminal prohormone of brain natriuretic peptide (NT-proBNP)
Cardiovascular system
Heart failure
+2 more

BeAT-HF Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Device and Medical ManagementExperimental Treatment2 Interventions
Subjects will be implanted with the BAROSTIM NEO System and receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs to be determined by the subject'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
Subjects will receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs to be determined by the subject'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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medical Management
2013
Completed Phase 4
~3060

Find a Location

Who is running the clinical trial?

CVRx, Inc.Lead Sponsor
20 Previous Clinical Trials
7,638 Total Patients Enrolled
11 Trials studying Heart Failure
6,359 Patients Enrolled for Heart Failure
Michael Zile, MDStudy ChairMedical University of South Carolina
4 Previous Clinical Trials
557 Total Patients Enrolled
4 Trials studying Heart Failure
557 Patients Enrolled for Heart Failure
William Abraham, MDPrincipal InvestigatorOhio State University
10 Previous Clinical Trials
3,944 Total Patients Enrolled
8 Trials studying Heart Failure
3,884 Patients Enrolled for Heart Failure

Media Library

BAROSTIM NEO® System (Device) Clinical Trial Eligibility Overview. Trial Name: NCT02627196 — N/A
Heart Failure Research Study Groups: Device and Medical Management, Medical Management
Heart Failure Clinical Trial 2023: BAROSTIM NEO® System Highlights & Side Effects. Trial Name: NCT02627196 — N/A
BAROSTIM NEO® System (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02627196 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there enrollment opportunities available for this research project?

"This study is no longer seeking participants, as the latest update on clinicaltrials.gov was made December 15th 2020 - since this initial posting in April 19th 2016. However, there are 694 other medical studies actively recruiting volunteers at present."

Answered by AI

In what capacity is this clinical trial being conducted across healthcare centers?

"At the time being, this trial is operational in 88 clinics across America. While there are sites located in Boise, Los Alamitos and Los Angeles, other places of operation can also be found. Consequently, it's advisable to select a site that limits travel arrangements for participants."

Answered by AI
~135 spots leftby Mar 2025