Barostim System for Heart Failure
(BENEFIT-HF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the Barostim System, a device designed to assist people with heart failure. The researchers aim to determine if this system can safely and effectively reduce heart failure symptoms and lower the risk of serious events, such as hospital stays or death, compared to current medications and treatments alone. Participants will either receive the Barostim System in addition to their usual treatment or continue with their usual treatment alone. This trial suits those with moderate heart failure symptoms who have maintained stable heart failure treatment for at least four weeks. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance future heart failure treatments.
What prior data suggests that the Barostim System is safe for heart failure patients?
Research has shown that the Barostim System is safe for people with heart failure. Studies found that this treatment improved patients' quality of life and physical abilities. Importantly, patients tolerated it well, experiencing fewer serious heart-related issues compared to those not receiving the treatment. Other research supports these findings, indicating that the Barostim System effectively manages heart failure symptoms. This device has been tested in various studies, consistently showing positive results with manageable safety risks.12345
Why are researchers excited about this trial?
The Barostim System is unique because it utilizes Baroreflex Activation Therapy (BAT) to treat heart failure. Unlike the standard treatments, which often include medications like beta-blockers or ACE inhibitors, the Barostim System involves an implanted device that actively stimulates the baroreceptors in the neck to regulate blood pressure and heart function. This novel approach can potentially improve heart performance and quality of life in ways that current drug therapies alone may not achieve. Researchers are excited about this treatment because it offers a new mechanism of action that could lead to more effective management of heart failure symptoms.
What evidence suggests that the Barostim System is effective for heart failure?
Research has shown that Baroreflex Activation Therapy (BAT) using the Barostim System effectively treats heart failure. In this trial, participants in the Device Arm will receive BAT with an implanted Barostim System alongside usual care medical management. Studies indicate that BAT improves patients' functional ability, enhances their quality of life, and boosts their exercise capacity. Specifically, patients who received BAT experienced fewer serious heart-related problems compared to those who only received standard care. Additionally, BAT significantly lowered the risk of death from heart-related issues and reduced other heart failure-related health problems. Overall, the evidence supports Barostim as a safe and effective treatment for people with heart failure.16789
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Baroreflex Activation Therapy (BAT) with the Barostim System or usual care medical management
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of all-cause mortality and heart failure morbidity
What Are the Treatments Tested in This Trial?
Interventions
- Barostim System
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive Baroreflex Activation Therapy (BAT) with an implanted Barostim System in addition to usual care medical management.
Participants will receive usual care medical management alone with no Barostim System device implant.
Find a Clinic Near You
Who Is Running the Clinical Trial?
CVRx, Inc.
Lead Sponsor
Citations
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.
Baroreflex Activation Therapy for the Treatment of Heart ...
➢ Within the first six months, BAT patients had significantly fewer serious cardiovascular adverse events than the Control patients. ➢ The ongoing BEAT-HF trial ...
Real-World Analysis of Health Care Utilization With ...
As Barostim was approved in 2019, the majority of implants (275/306; 90%) and follow-up occurred in 2021 to 2023. Mean age was 66 ± 12 years, 79 (25.8%) were ...
4.
tctmd.com
tctmd.com/news/baroreflex-activation-advanced-hf-yields-positive-results-postmarketing-dataBaroreflex Activation for Advanced HF Yields Positive Results
Six months after implantation of Barostim, there were no significant changes in NT-proBNP, renal function, systolic or diastolic blood pressure, ...
5.
barostim.com
barostim.com/wp-content/uploads/2022/02/Response-To-Barostim-Therapy-By-Atrial-Fibrillation-Status-paper.pdfResponse to Baroreflex Activation Therapy (BAT) By Atrial ...
Outcomes • BAROSTIM Therapy is safe. • Mechanism of action demonstrated through muscle sympathetic nerve activity & HR. Variability. • BAROSTIM Therapy is safe ...
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.
284 Barostim, NT-proBNP, And Clinical Outcomes In Heart ...
The Baroreflex Activation Therapy for Heart Failure (BeAT-HF) randomized controlled trial showed Barostim was safe, improved quality of life, exercise ...
Sustained Improvement in Specific Quality-of-Life Domains ...
Barostim delivers Baroreflex Activation Therapy for improvement of patients' heart failure functional status, six-minute hall walk, and quality of life.
SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)
The BAROSTIM NEO® System is indicated for the improvement of symptoms of heart failure – quality of life, six-minute hall walk and ...
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