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

CVRx

Status: Active, not recruiting

Conditions: High Blood Pressure

Treatments: Drug: Medical Management; Device: BAROSTIM NEO System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01471834

360016

Details and patient eligibility

About

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

Full 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

Enrollment: 40 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Device and Medical Management

Experimental group

Description:

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.

Treatment:

Device: BAROSTIM NEO System

Drug: Medical Management