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Device

Device and Medical Management for Heart Failure

N/A
Waitlist Available
Led By Uta Hoppe, 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 for the duration of the study, up to 5 years.
Awards & highlights

Study Summary

The purpose of this portion of study NCT01471860 is to assess the long-term safety and efficacy of the BAROSTIM NEO System in Canadian study participants implanted with the device.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for the duration of the study, up to 5 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and for the duration of the study, up to 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
To assess long-term adverse events in Canadian participants implanted with the BAROSTIM NEO System

Trial Design

1Treatment groups
Experimental Treatment
Group I: Device and Medical ManagementExperimental Treatment2 Interventions
Medical Management, to be determined by the participant's physician, described as: Optimal pharmacological therapy: Prescribed to a beta blocker, a diuretic, and an ACE (Angiotensin-converting-enzyme) inhibitor or ARB (Angiotensin Receptor Blocker) unless contraindicated or not tolerated. These drugs must be used in a manner consistent with their labeling. Stable pharmacological therapy: No more than a 50% increase or a 50% decrease of the dosage of any one medication, and post titration of all heart failure medications. Participants should remain on their prescribed heart failure medications and same dosing schedule for the duration of the study unless investigators determine medically necessary changes are needed. Additionally, every effort should be made to maintain adequate rate control for subjects with atrial fibrillation throughout the duration of the study.
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
8,744 Total Patients Enrolled
11 Trials studying Heart Failure
7,465 Patients Enrolled for Heart Failure
Uta Hoppe, MDPrincipal InvestigatorUniversity of Cologne

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 NEO System in the Treatment of Heart Failure
2011. "BAROSTIM NEO System in the Treatment of Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01471860.
All > Heart Failure With Preserved Ejection Fraction
~7 spots leftby Apr 2025
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