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Life sciences · Interventional Study
ClinicalTrials.gov · October 1, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Interventional Study.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT04600791). This is a study registration, not published results. Lead sponsor: CVRx, Inc.. Recruitment status: TERMINATED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 93 participants (ACTUAL). Conditions: Heart Failure. Interventions: DEVICE: BATwire Implant Kit. Primary outcome measures: Number of Participants Without Serious Adverse Events (SAEs) Related to the Implantation of the Lead Using the BATwire Implant Kit Through 30 Days Post-implant. , 30 days post-implant; Change in Six Minute Hall Walk (6MHW) Distance Walked , From baseline to 6 months of follow-up, post-implant. Brief summary: The purpose of this clinical investigation is to develop valid scientific evidence for the safety and effectiveness of the Barostim System delivered by the BATwire Implant Kit (BATwire Kit) in subjects with heart failure. Subjects may be enrolled if they meet the FDA approved PMA indication for use for the Barostim NEO or Barostim NEO2 device: Subjects who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT-proBNP \< 1600 pg/ml and excludes patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.