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

NCT01471834 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 360016
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 9

Brief Summary

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

Conditions

High Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Device and Medical Management

EXPERIMENTAL

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; Drug: Medical Management

Interventions

BAROSTIM NEO System DEVICE

Also known as: XR-1 System, Neo System

Device and Medical Management

Medical Management DRUG

Device and Medical Management

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Actively participating in the Neo Non-Randomized Hypertension Study.
• Have signed a revised approved informed consent form for continued participation in this study.

You may not qualify if:

• Treating physician decision that the subject should not continue with therapy.

Sponsors & Collaborators

• CVRx, Inc.: lead

Study Sites (9)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta - Edmonton

Edmonton, Alberta, T2P 1C4, Canada

Location

London-Lawson Health Research Institute

London, Ontario, N6G 2V2, Canada

Location

University Hospital Cologne

Cologn, 50924, Germany

Location

University Hospital Duesseldorf

Düsseldorf, 40225, Germany

Location

Goettingen-Georg August University

Göttingen, 37075, Germany

Location

Midizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Klinkum St. George Leipzig

Leipzig, 04129, Germany

Location

Maastricht University

Maastricht, HX6229, Netherlands

Location

Related Publications (1)

• Wachter R, Halbach M, Bakris GL, Bisognano JD, Haller H, Beige J, Kroon AA, Nadim MK, Lovett EG, Schafer JE, de Leeuw PW. An exploratory propensity score matched comparison of second-generation and first-generation baroreflex activation therapy systems. J Am Soc Hypertens. 2017 Feb;11(2):81-91. doi: 10.1016/j.jash.2016.12.003. Epub 2016 Dec 16.

  PMID: 28065708 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Practice Management, Medical

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Hermann Haller, MD

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 16, 2011
• Study Start: June 1, 2011
• Primary Completion: May 1, 2012
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

NL (1); CA (3); DE (5)