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

N/AActive Not RecruitingNCT01471834

CVRx, Inc.40 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

High Blood Pressure

Interventions

BAROSTIM NEO SystemDEVICE

Medical ManagementDRUG

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (9)

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

Outcomes

Primary Outcomes

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.

Time frame: For the duration of the study, up to 10 years.

Data from ClinicalTrials.gov

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