BATwire Implant Kit Study

About the trial

Sponsor

CVRx, Inc.

Tested

BATwire Implant Kit (device)

Dates

Started 2021-01-29; completion 2025-02-17

Results posted

Yes

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.

From ClinicalTrials.gov, last updated 2026-10-01. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Cvrx, Inc. reported $152,488 in research payments for this study in 2025 (21 payments).

Products named: Barostim Neo System

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.