Barostim Neo™ System / Heart Failure · Observational Study

BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction

ClinicalTrials.gov · September 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered observational registry study of the Barostim Neo System in heart failure with reduced ejection fraction, currently recruiting. No efficacy or safety data are reported in this registry record; the study is designed to collect functional, biomarker, and hospitalization outcomes over 12 months post-implant in a commercial real-world setting.

What was studied

Observational. Heart Failure. Intervention: Barostim Neo™ System. n = 500. 30 sites: Germany, Italy.

Key findings

Safety

Primary outcomes include both functional measures and biomarkers but no stated hard clinical endpoint (e.g. mortality, cardiac events).

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an active observational registry record with no reported results; it describes a planned study of device therapy in heart failure that is currently recruiting participants.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measures: Change in New York Heart Association Functional Classification at 6 months Post-Implant (assessed at Baseline, 6 months post-implant); Change in Six Minute Hall Walk from Baseline to 6 months Post-Implant (assessed at Baseline, 6 months post-implant); Left Ventricular Mass Index Change from Baseline to 6 Months Post-Implant (assessed at Baseline, 6 months post-implant); Change in Biomarkers from Baseline to 6 months Post-Implant (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C) (assessed at Baseline, 6 months post-implant);…

DesignObservational

PopulationHeart Failure

Sample size500

InterventionBarostim Neo™ System

Setting30 sites: Germany, Italy

Reported figures

Quoted from the source exactly as published.

Planned enrollment500

Primary outcome measure 1Change in New York Heart Association Functional Classification at 6 months Post-Implant

Primary outcome measure 2Change in Six Minute Hall Walk from Baseline to 6 months Post-Implant

Primary outcome measure 3Left Ventricular Mass Index Change from Baseline to 6 Months Post-Implant

Primary outcome measure 4Change in Biomarkers from Baseline to 6 months Post-Implant (NT-pro BNP, eGFR, Troponin HsT, Cystatin C)

Primary outcome measure 5Number of Hospitalizations over Follow-Up at 12 months post-implant

Caveats

This is a registry record only; no results are reported or available.
Study is actively recruiting; follow-up data collection is ongoing.
Observational design without control arm or randomization limits causal inference.
Primary outcomes include both functional measures and biomarkers but no stated hard clinical endpoint (e.g. mortality, cardiac events).

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Observational registry without control group or randomization.

Directness

moderate

Measures functional status, biomarkers, and hospitalizations relevant to HFrEF.

Consistency

insufficient

No results reported; consistency cannot be assessed.

Risk of bias

insufficient

Registry design without blinding or comparator; bias assessment premature.

Sample adequacy

moderate

Estimated 500 participants planned; enrollment still ongoing.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT02880618). This is a study registration, not published results. Lead sponsor: CVRx, Inc.. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 500 participants (ESTIMATED). Conditions: Heart Failure. Interventions: DEVICE: Barostim Neo™ System. Primary outcome measures: Change in New York Heart Association Functional Classification at 6 months Post-Implant , Baseline, 6 months post-implant; Change in Six Minute Hall Walk from Baseline to 6 months Post-Implant , Baseline, 6 months post-implant; Left Ventricular Mass Index Change from Baseline to 6 Months Post-Implant , Baseline, 6 months post-implant; Change in Biomarkers from Baseline to 6 months Post-Implant (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C) , Baseline, 6 months post-implant; Number of Hospitalizations over Follow-Up , 12 months post-implant. Brief summary: 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).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

CVRxBarostim Neo™ SystemHeart FailureNCT02880618