Barostim Neo™ System / Heart Failure · Observational Study

BAROSTIM THERAPY™ In Heart Failure With Preserved 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 registry record documenting a completed observational study of BAROSTIM NEO therapy in 11 patients with heart failure with preserved ejection fraction and resistant hypertension. No results are reported in this registry entry, and the observational design without controls limits the strength of inference about efficacy.

What was studied

Observational. Heart Failure. Intervention: BAROSTIM NEO™ System. n = 11. 13 sites: Germany.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This registry record describes a planned or completed observational study but reports no outcomes. Clinicians should not draw conclusions about efficacy from this registry entry alone; results must be awaited in published form.

Plain-language summary

Registry record of a completed observational study with 11 participants evaluating a device intervention in a specific HFpEF population; no results are reported in this registration.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: Changes in Office Cuff Systolic Blood Pressure (assessed at Pre-implant baseline to 6 months post-implant)

DesignObservational

PopulationHeart Failure

Sample size11

InterventionBAROSTIM NEO™ System

Setting13 sites: Germany

Reported figures

Quoted from the source exactly as published.

Sample size11

Primary outcome measureChanges in Office Cuff Systolic Blood Pressure, Pre-implant baseline to 6 months post-implant

Study typeObservational

Recruitment statusCompleted

Clinical bottom line

Caveats

No results are posted in this registry record; outcome data are not reported
Observational design without control or comparison arm limits causal inference
Very small sample size (11 participants) limits generalizability
No information on baseline characteristics, follow-up duration details, or analysis approach

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

Evaluates device effect in commercial setting in HFpEF patients with resistant hypertension

Consistency

insufficient

No comparative data or multiple studies reported in registry record

Risk of bias

limited

Observational design without blinding or control; registry record provides no methodological detail

Sample adequacy

limited

11 participants enrolled; sample size not powered for hypothesis testing

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 (NCT02876042). This is a study registration, not published results. Lead sponsor: CVRx, Inc.. Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 11 participants (ACTUAL). Conditions: Heart Failure. Interventions: DEVICE: BAROSTIM NEO™ System. Primary outcome measures: Changes in Office Cuff Systolic Blood Pressure , Pre-implant baseline to 6 months post-implant. Brief summary: The purpose of this registry (NCT02876042) 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 resistant hypertension that also have evidence of heart failure with preserved ejection fraction (HFpEF).

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 FailureNCT02876042