BAROSTIM NEO System for High Blood Pressure

N/A

Waitlist Available

Led By Hermann Haller, MD

Research Sponsored by CVRx, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for the duration of the study, up to 10 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at the long-term safety and effectiveness of a device called the BAROSTIM NEO System.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, generally, device-related treatments like BAROSTIM NEO may cause discomfort at the implant site, infection risk, or nerve damage. Medical management side effects depend on the drugs used.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for the duration of the study, up to 10 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for the duration of the study, up to 10 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and for the duration of the study, up to 10 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Device and Medical ManagementExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Medical Management

2013

Completed Phase 4

~3060

Do I qualify?Apply below to find out