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

NCT ID: NCT01471834

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2026-08-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device and Medical Management

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.

Group Type: EXPERIMENTAL

BAROSTIM NEO System

Intervention Type: DEVICE

Medical Management

Intervention Type: DRUG

Interventions

BAROSTIM NEO System

Intervention Type: DEVICE

Medical Management

Intervention Type: DRUG

Other Intervention Names

XR-1 System; Neo System

Eligibility Criteria

Inclusion Criteria

• Actively participating in the Neo Non-Randomized Hypertension Study.
• Have signed a revised approved informed consent form for continued participation in this study.

Exclusion Criteria

• Treating physician decision that the subject should not continue with therapy.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CVRx, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hermann Haller, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

University of Calgary

Calgary, Alberta, Canada

University of Alberta - Edmonton

Edmonton, Alberta, Canada

London-Lawson Health Research Institute

London, Ontario, Canada

University Hospital Cologne

Cologn, , Germany

University Hospital Duesseldorf

Düsseldorf, , Germany

Goettingen-Georg August University

Göttingen, , Germany

Midizinische Hochschule Hannover

Hanover, , Germany

Klinkum St. George Leipzig

Leipzig, , Germany

Maastricht University

Maastricht, , Netherlands

Countries

Canada; Germany; Netherlands

References

Wachter R, Halbach M, Bakris GL, Bisognano JD, Haller H, Beige J, Kroon AA, Nadim MK, Lovett EG, Schafer JE, de Leeuw PW. An exploratory propensity score matched comparison of second-generation and first-generation baroreflex activation therapy systems. J Am Soc Hypertens. 2017 Feb;11(2):81-91. doi: 10.1016/j.jash.2016.12.003. Epub 2016 Dec 16.

Reference Type: DERIVED

PMID: 28065708 (View on PubMed)

Other Identifiers

360016

Identifier Type: -

Identifier Source: org_study_id