Barostim Therapy for Heart Failure

Not currently recruiting at 50 trial locations

Overseen By Laura Menck

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: CVRx, Inc.

Disqualifiers: Baroreflex failure, Autonomic neuropathy, others

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial assesses the safety and benefits of Barostim Therapy, a device-based treatment for individuals with heart failure with reduced ejection fraction (HFrEF). The treatment aims to improve symptoms such as quality of life and daily function for those who continue to experience symptoms despite following standard medical advice. Individuals who have recently had the Barostim System implanted and still experience heart failure symptoms, even with regular treatment, might be suitable candidates. The trial excludes those requiring a specific heart therapy called Cardiac Resynchronization Therapy (CRT). As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It seems like you can continue your existing treatments, as the Barostim System is for patients who still have symptoms despite following their current medical therapy.

What is the safety track record for Barostim Therapy?

Research has shown that Barostim Therapy is generally safe for patients. Studies have found that most people tolerate the treatment well, with 97.2% of patients not experiencing major brain or heart problems. The FDA has approved Barostim Therapy for use in heart failure patients in the United States, indicating it meets high safety standards. Although some risks exist, current data supports a strong safety profile for this treatment. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Barostim Therapy is unique because it targets the nervous system to help manage heart failure, unlike most treatments that focus on blocking harmful substances or reducing fluid overload. This therapy uses a small device implanted under the skin to send electrical signals to the brain, which can help regulate heart function and blood pressure. Researchers are excited about Barostim because it offers a novel approach by directly influencing the nervous system, potentially improving quality of life for patients who may not respond well to conventional medications or devices.

What evidence suggests that Barostim Therapy is effective for heart failure with reduced ejection fraction?

Research has shown that Barostim Therapy holds promise for treating heart failure with reduced ejection fraction (HFrEF). Studies have found that this therapy improves heart failure symptoms and enhances quality of life. Specifically, patients have experienced significant and lasting benefits for 12 to 24 months. The therapy activates a natural body mechanism that helps control blood pressure and heart function. Overall, Barostim Therapy is considered safe and effective for improving heart function in patients with HFrEF. ^{3 5 6 7 8}

Who Is on the Research Team?

Thomas Deering

Principal Investigator

Piedmont Heart Institute

Bradley Knight

Principal Investigator

Northwestern Medicine

Larry Chinitz

Principal Investigator

NYU Heart Rhythm Center

Michael Gold

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

Inclusion Criteria

Bilateral carotid bifurcations located above the level of the mandible

Patients can be included in the registry if they were implanted with a de novo Barostim System. Patients must sign an informed consent form after implantation with the Barostim System in order to participate in the registry.

The Barostim System is indicated for the improvement of symptoms of heart failure - quality of life, six-minute hall walk and functional status - for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a NT-proBNP < 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Participants are implanted with the Barostim System

1 day

1 visit (in-person)

Post-implant Monitoring

Participants are monitored every six months after device implant

36 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Barostim Therapy

Who Is Running the Clinical Trial?

CVRx, Inc.

Lead Sponsor

Trials

21

Recruited

8,500+

Citations

1. barostim.com barostim.com/healthcare-professionals/beat-hf-trial/

BeAT-HF | Pivotal Clinical Trial Results | Barostim Therapy View the BeAT-HF Trial results and see how Barostim™ achieved significant and meaningful improvements in heart failure symptoms. Learn more today!

2. evtoday.com evtoday.com/news/cvrx-barostims-safety-and-effectiveness-evaluated-in-long-term-data-from-beat-hf-trial

CVRx Barostim's Safety and Effectiveness Evaluated in ... Overall, the 12- to 24-month therapeutic benefit from BAT was consistent with previously reported efficacy through 6 months. There was a durable ...

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

Barostim Baroreflex Activation Therapy In this study, BAT with the Barostim neo™ system resulted in a decrease in BP by 26/12 mm Hg at 6 months (p<0.001 for both) with three minor ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10567643/

Efficacy and safety of baroreflex activation therapy for heart ... The results show that BAT is safe and improves functional class, quality of life and congestion in selected patients with HFrEF.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2468428724000480

Early experience with baroreflex activation therapy from a ... Three patients (27.3%) experienced extraneous stimulations, which affected BAT tolerability. Within 6 months after BAT implantation, no significant improvements ...

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

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) CVRx has performed research and Good Laboratory Practice (GLP) safety evaluations of BAROSTIM THERAPY using BAROSTIM NEO System, in an ovine ...

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. ahajournals.org ahajournals.org/doi/10.1161/circ.148.suppl_1.13319

Abstract 13319: The Barostim Baroreflex Activation ... Abstract 13319: The Barostim Baroreflex Activation Therapy System: Safety Insights From FDA MAUDE Database | Circulation.