BAROSTIM NEO System for High Blood Pressure

Not currently recruiting at 10 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CVRx, Inc.

Disqualifiers: Physician decision, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Duration of the study

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the BAROSTIM NEO System to determine if it safely and effectively helps manage high blood pressure over time. The device complements standard medical treatments for heart issues. Individuals already participating in a specific hypertension study and wishing to continue are well-suited for this trial. The goal is to enhance the effectiveness of these treatments in maintaining healthy blood pressure levels. As an unphased trial, it provides a unique opportunity to contribute to innovative research that could improve future treatment options.

Do I need to stop my current medications for the BAROSTIM NEO trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What prior data suggests that the BAROSTIM NEO System is safe for high blood pressure?

Research shows that the BAROSTIM NEO System is designed for individuals with heart failure or high blood pressure unresponsive to regular treatment. Studies have found that most patients tolerate this system well. A simple procedure, not requiring major surgery, places the device.

Previous studies mention possible side effects, such as mild discomfort or pain at the implantation site. However, serious side effects are rare. The FDA has approved the system for heart failure and resistant high blood pressure, confirming it meets safety standards for these conditions.

Overall, past studies indicate that the BAROSTIM NEO System has a good safety record. It works by activating the body's natural systems to help control blood pressure, effectively using the body's own abilities to assist with treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for high blood pressure involve medications that adjust the balance of fluids or relax blood vessels, like beta blockers or ACE inhibitors. But the BAROSTIM NEO System works differently, targeting the nervous system directly. It uses a small device implanted in the body that sends electrical signals to the brain, helping to naturally regulate blood pressure by activating the body's own baroreflex system. Researchers are excited about this innovative approach because it offers a new avenue for patients who might not respond well to traditional medications, potentially providing better control of blood pressure with fewer side effects.

What evidence suggests that the BAROSTIM NEO System is effective for high blood pressure?

Research has shown that the BAROSTIM NEO System, which participants in this trial will receive, can lower blood pressure and improve heart health. In earlier studies, people using this device exercised more easily and felt better overall. The system helps the body naturally manage blood pressure. Studies also found a decrease in certain blood substances that indicate heart stress. These results suggest that the BAROSTIM NEO System could be a promising treatment for those with high blood pressure and heart problems. ^{6 7 8 9 10}

Who Is on the Research Team?

Hermann Haller, MD

Principal Investigator

Hannover Medical School

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are implanted with the BAROSTIM NEO System and continue on stable, guideline-directed medical therapy for hypertension

Duration of the study

Long-term Follow-up

Participants are monitored for safety and efficacy, with annual visits assessing physical health, blood pressure, medications, and adverse events

Up to 10 years

At least 1 annual visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BAROSTIM NEO System

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

The Barostim Neo™ device for baroreflex activation therapy (BAT) was safely implanted in 30 patients with heart failure with reduced ejection fraction (HFrEF), leading to significant improvements in clinical symptoms and modest improvements in left ventricular function over 12 months.

Despite these improvements, the risk of death remained high, particularly in patients with advanced heart failure (NYHA Class IV) and elevated NT-proBNP levels, highlighting the importance of careful patient selection for BAT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baroreflex activation therapy in patients with heart failure with reduced ejection fraction: a single-centre experience. Blanco, C., Madej, T., Mangner, N., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6442942/

DEVICE-BASED NEUROMODULATION FOR RESISTANT ... Appreciable BP lowering was achieved in both studies without the side effects reported in clinical studies using Barostim neo. However, in contrast to ...

2. barostim.com barostim.com/cvrx-barostim-therapy-for-heart-failure-clinical-trial-results-presented-in-a-featured-clinical-research-session-of-the-american-college-of-cardiology-annual-conference/

BAT Presented in a Featured Clinical Research Session “Barostim proved to be safe and significantly improved patient functional status, quality of life score, exercise capacity, serum biomarkers of heart failure ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02880631

BAROSTIM THERAPY™ In Resistant Hypertension The purpose of this registry (NCT02880631) is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM NEO System in the commercial setting in subjects ...

4. aetna.com aetna.com/cpb/medical/data/800_899/0820.html

Carotid Sinus Stimulation for Hypertension In a single-arm, open-label study, Hoppe and associates (2012) evaluated the effectiveness of the Barostim neo™ system, a 2nd-generation system for delivering ...

5. acc.org acc.org/Latest-in-Cardiology/Articles/2022/12/02/13/14/Barostim-Baroflex-Activation-Therapy

Barostim Baroreflex Activation Therapy At 6 months, BAT resulted in a significant improvement in MLHFQ score and 6-minute walk distance and reduction in the levels of NT-proB-type ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/H130007b.pdf

summary of safety and probable benefit (sspb) The Barostim neo® Legacy System is indicated for use in patients with resistant hypertension who have had bilateral implantation of the Rheos. ®. Carotid ...

7. barostim.com barostim.com/important-safety-regulatory-information/

Important Safety & Regulatory Information | Benefit Risk ... View the reported and potential benefits and hazards for patients/subjects treated with Barostim™ and other safety & regulatory information.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf18/P180050b.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The minimally-invasive BAROSTIM NEO System uses CVRx patented BAROSTIM THERAPY® technology to trigger the body's own natural systems by.

9. barostim.com barostim.com/wp-content/ifu/international/english/900097-001G_Barostim-Therapy-Reference-Guide-for-Heart-Failure-and-Hypertension_CE-marking.pdf

barostim neo BAROSTIM NEO System is indicated for patients with heart failure or resistant hypertension. ... ▫ Blood pressure monitoring equipment (such as an arterial ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT01471834?cond=Hypertension&viewType=Table&term=hydralazine&checkSpell=&rank=9

Study Details | Verification of the Efficacy and Safety of the ... Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.