BAROSTIM NEO System for High Blood Pressure

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen by Hermann Haller, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: CVRx, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

Hermann Haller, MD

Principal Investigator

Hannover Medical School

Eligibility Criteria

This trial is for people with high blood pressure that doesn't get better with medication. Participants must already be part of the Neo Non-Randomized Hypertension Study and have agreed to keep participating by signing a consent form. If their doctor thinks they shouldn't continue, they can't join.

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.

Treatment Details

Interventions

• BAROSTIM NEO System (Device)

Trial Overview The study is looking at how safe and effective the BAROSTIM NEO System is over a long time in patients who are already using it from an earlier study (NCT01471834). It compares regular medical management of high blood pressure with this system.

Participant Groups

Group I: Device and Medical Management Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

CVRx, Inc.

Lead Sponsor

Trials

21

Recruited

8,500+