NCT01679132

BAROSTIM NEO Hypertension Pivotal Trial

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: CVRx, Inc. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical investigation (NCT01679132) is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM Hypertension Pivotal Trial (G120137).

Detailed description

The BAROSTIM NEO Hypertension Trial is a prospective, randomized, controlled trial assessing the safety and efficacy of the BAROSTIM NEO System in subjects with resistant hypertension. All subjects are now in long term follow-up and are required to have at least one annual visit. Parameters assessed during visits are: * Office Cuff Blood Pressure * Physical Assessment * Subject Medications * Serious adverse events

Conditions

• Uncontrolled Hypertension

Interventions

Type	Name	Description
DEVICE	BAROSTIM NEO System and Medical Management	Experimental: Device and Medical Management Subjects have been implanted with the BAROSTIM NEO System and receive optimal medical management, including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics; Thiazide Diuretics; Potassium-sparing Diuretics; Aldosterone receptor blockers; Beta-blockers; Beta-blockers with intrinsic sympathomimetic activity; Combined alpha- and beta-blockers; ACE inhibitors; Angiotensin II antagonists; Calcium channel blockers- non-Dihydropyridines; Calcium channel blockers- Dihydropyridines; Alpha1-blockers; Central alpha2-agonists and other centrally acting drugs; Direct vasodilators.

Timeline

• Start date: 2013-04-12
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2012-09-05
• Last updated: 2025-07-15

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study