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

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

Detailed Description
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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

Official Title
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Neo Non-Randomized Hypertension Study

Conditions
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High Blood Pressure

Intervention / Treatment
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* Device: BAROSTIM NEO System
* Drug: Medical Management


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device and Medical Management<br>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. | Device: BAROSTIM NEO System<br> <br> * Other names: Neo System;Drug: Medical Management<br> <br> |

What is the study measuring?
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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. |