An interventional study of BAROSTIM NEO System and Medical Management in High Blood Pressure, sponsored by CVRx, Inc.. Active, not recruiting at 9 sites in 3 countries. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by CVRx, Inc. · Not applicable, Interventional, and Treatment
To assess the long-term safety and efficacy of the BAROSTIM NEO System in trial (NCT01471834) participants.
The Neo Non-Randomized Hypertension Study is a non-randomized, open-label, verification study in participants diagnosed with drug resistant hypertension, defined as medical treatment failure for hypertension defined as office cuff systolic blood pressure (SBP) ≥ 140 mmHg despite being prescribed to at least three antihypertensive medications, including a diuretic, in accordance with the AHA guidelines.
Participants should remain on their prescribed anti-hypertensive medications and same dosing schedule for the duration of the study unless investigators determine medically necessary changes are needed. Additionally, every effort should be made to maintain adequate rate control for subjects with atrial fibrillation throughout the duration of the study.
All (Canadian) participants are now in long term follow-up and are required to have at least one annual visit.
Parameters assessed during long-term follow-up visits:
6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.
This study's enrollment of 40 is below the median of 90 across 4,994 interventional studies indexed under Hypertension.
Browse Hypertension studies →CVRx, Inc. is the lead sponsor of 19 studies on the registry; 4 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be implanted with the BAROSTIM NEO System and will continue to receive optimal, stable, Guideline Directed Medical Therapy (GDMT) for heart failure (American Heart Association \[AHA\] / American College of Cardiology \[ACC\] guidelines), including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
Device: BAROSTIM NEO System · Drug: Medical Management
Also known as: XR-1 System, Neo System
To access long-term adverse events in participants implanted with the BAROSTIM NEO System.
Ascertain the type, frequency, severity and timing of long-term adverse events in participants implanted with the device, while providing a viable treatment option to participants currently implanted with CVRx's BAROSTIM NEO System.
Time frame: For the duration of the study, up to 10 years.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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CVRx, Inc.