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

Not Applicable

Active, not recruiting

• Conditions: High Blood Pressure
• Interventions: Device: BAROSTIM NEO System; Drug: Medical Management

• Registration Number: NCT01471834
• Lead Sponsor: CVRx, Inc.

Brief Summary

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

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

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-16
• Primary Completion: 2012-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-28
• Last Update Posted: 2024-07-01
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device and Medical Management	BAROSTIM NEO System	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 and Medical Management	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.

Primary Outcome Measures

Name	Time	Method
To access long-term adverse events in participants implanted with the BAROSTIM NEO System.	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.

Trial Locations

Locations (9)

University of Alberta - Edmonton; 🇨🇦 Edmonton, Alberta, Canada

University Hospital Cologne; 🇩🇪 Cologn, Germany

Klinkum St. George Leipzig; 🇩🇪 Leipzig, Germany

Maastricht University; 🇳🇱 Maastricht, Netherlands

London-Lawson Health Research Institute; 🇨🇦 London, Ontario, Canada

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

University Hospital Duesseldorf; 🇩🇪 Duesseldorf, Germany

Midizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Goettingen-Georg August University; 🇩🇪 Göttingen, Germany