BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCVRx, Inc.
About this trial
The purpose of this registry (NCT02880618) is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM NEO System in the commercial setting in subjects recently implanted under the CE-Marked indication for heart failure with reduced ejection fraction (HFrEF).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject has heart failure, defined as New York Heart Association (NYHA) functional Class III and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy
Subject has been implanted with the BAROSTIM NEO System in the past 30 days
Subject has signed an Ethics Committee approved informed consent form
Disqualifiers
Bilateral carotid bifurcations located above the level of the mandible
Baroreflex failure or autonomic neuropathy
Uncontrolled, symptomatic cardiac bradyarrhythmias
Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50%
Trial population
Subjects can be included in the Heart Failure with Reduced Ejection Fraction Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications, and are not contraindicated, for the BAROSTIM NEO System in the treatment of heart failure.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Barostim Neo™ System
Device
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Change in New York Heart Association Functional Classification at 6 months Post-Implant
To demonstrate that that treatment with BAROSTIM NEO improves New York Heart Association classification.
Time frame
Baseline, 6 months post-implant2
Change in Six Minute Hall Walk from Baseline to 6 months Post-Implant
To demonstrate that that treatment with BAROSTIM NEO improves six-minute hall walk performance.
Time frame
Baseline, 6 months post-implant3
Left Ventricular Mass Index Change from Baseline to 6 Months Post-Implant
To demonstrate that that treatment with BAROSTIM NEO reduces left ventricular mass index.
Time frame
Baseline, 6 months post-implant4
Change in Biomarkers from Baseline to 6 months Post-Implant (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C)
To demonstrate that that treatment with BAROSTIM NEO improves biomarker results.
Time frame
Baseline, 6 months post-implant Source ClinicalTrials.gov