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

Overview

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

Full Title of Study: “Neo Non-Randomized Hypertension Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2012

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

Interventions

  • Device: BAROSTIM NEO System
  • Drug: Medical Management

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • To access long-term adverse events in participants implanted with the BAROSTIM NEO System.
    • Time Frame: For the duration of the study, up to 10 years.
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • CVRx, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hermann Haller, MD, Principal Investigator, Hannover Medical School

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