NCT01471834

Verification of the Efficacy and Safety of the BAROSTIM NEO System in the Treatment of Drug Resistant Hypertension

Neo Non-Randomized Hypertension Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: CVRx, Inc. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To assess the long-term safety and efficacy of the BAROSTIM NEO System in trial (NCT01471834) participants.

Detailed description

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: * Physical Assessment * Office Cuff Blood Pressure * Subject Medications * Serious adverse events

Conditions

• High Blood Pressure

Interventions

Type	Name	Description
DEVICE	BAROSTIM NEO System
DRUG	Medical Management

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-05-01
• Completion: 2026-08-01
• First posted: 2011-11-16
• Last updated: 2025-07-15

Locations

9 sites across 3 countries: Canada, Germany, Netherlands

Regulatory

• FDA-regulated device study