BAROSTIM NEO Hypertension Pivotal Trial

Study Overview
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Brief Summary
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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
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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

Official Title
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BAROSTIM NEO Hypertension Pivotal Trial

Conditions
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Uncontrolled Hypertension

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Actively participating in the Barostim Hypertension Pivotal Trial and currently implanted with the BAROSTIM NEO device with the device turned ON. 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: BAROSTIM NEO System<br>Subjects implanted with the BAROSTIM NEO System. | Device: BAROSTIM NEO System and Medical Management<br>* 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.<br>* Other names: Neo System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System. | Ascertain the type, frequency, severity and timing of long-term adverse events in G120137 study subjects implanted with the device, while providing a viable treatment option to patients currently implanted with the CVRx BAROSTIM NEO System. | For the duration of the study, up to ten years. |