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

Neo Non-Randomized Hypertension Study

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

Study Overview

• Status: Active, not recruiting
• Conditions: High Blood Pressure
• Intervention / Treatment: Drug: Medical Management; Device: BAROSTIM NEO System

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • University of Calgary
    • Edmonton, Alberta, Canada, T2P 1C4
      • University of Alberta - Edmonton
  • Ontario
    • London, Ontario, Canada, N6G 2V2
      • London-Lawson Health Research Institute
• Germany
  • Cologn, Germany, 50924
    • University Hospital Cologne
  • Duesseldorf, Germany, 40225
    • University Hospital Duesseldorf
  • Göttingen, Germany, 37075
    • Goettingen-Georg August University
  • Hannover, Germany, 30625
    • Midizinische Hochschule Hannover
  • Leipzig, Germany, 04129
    • Klinkum St. George Leipzig
• Netherlands
  • Maastricht, Netherlands, HX6229
    • Maastricht University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: Medical Management; Device: BAROSTIM NEO System; Other Names: XR-1 System; Neo System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	For the duration of the study, up to 10 years.

Collaborators and Investigators

• Sponsor: CVRx, Inc.
• Investigators: Principal Investigator: Hermann Haller, MD, Hannover Medical School

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 9, 2011
• First Submitted That Met QC Criteria: November 10, 2011
• First Posted (Estimated): November 16, 2011

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 360016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes