BaroStim for Heart Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a device called BaroStim to help manage heart failure symptoms. BaroStim stimulates the body's natural reflexes to improve heart function. The trial seeks individuals diagnosed with NYHA Class III heart failure who have had a CardioMems device inserted in the past three months. Those who fit this description and can handle oral medications might be suitable for this study. As a Phase 2, Phase 3 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group and is in the final step before FDA approval. This offers participants a chance to contribute to a potentially groundbreaking heart failure treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it mentions a period of medication management and optimization. It's best to discuss your specific medications with the trial team.
What prior data suggests that the BaroStim device is safe for heart failure patients?
Research has shown that BaroStim is safe for people with heart failure. Studies have found that it can improve quality of life and enhance heart function. Most importantly, it is well-tolerated, with most people experiencing no serious side effects.
For those with heart failure, BaroStim reduces symptoms and improves heart function. This evidence suggests that BaroStim is a safe option for enhancing heart health in eligible patients.1234Why do researchers think this study treatment might be promising?
BaroStim is unique because it uses a novel approach to manage heart failure by targeting the autonomic nervous system. Unlike standard treatments like beta-blockers or ACE inhibitors, which primarily focus on heart function and blood pressure, BaroStim works by stimulating baroreceptors, which are sensors in your blood vessels that help regulate heart rate and blood pressure. This method offers a new way to potentially improve heart function and quality of life for patients with NYHA Class III heart failure. Researchers are excited about BaroStim because it provides a non-drug option that could complement existing therapies and offer relief to patients who haven't responded well to traditional treatments.
What evidence suggests that the BaroStim device is effective for heart failure?
Research has shown that BaroStim, a therapy activating certain body reflexes, benefits people with heart failure. Studies indicate it improves heart function and quality of life. Participants in this trial will receive BaroStim, and previous research demonstrated that patients using BaroStim experienced fewer serious heart problems compared to those who did not. Evidence also shows it reduces heart strain, as indicated by lower levels of NT-proBNP, a substance linked to heart failure. Real-world data suggests BaroStim helps reduce hospital visits for heart issues. Overall, BaroStim appears to be a promising option for managing heart failure.34567
Who Is on the Research Team?
John Kassotis, MD
Principal Investigator
Northwell Health
Are You a Good Fit for This Trial?
This trial is for heart failure patients who have had a CardioMems device inserted and undergone 3 months of medication management. Ideal candidates are those now considered for BaroStim therapy, which aims to optimize heart function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Medication Management
Patients undergo 3 months of medication management and titration after CardioMems insertion
BaroStim Insertion and Titration
Insertion and titration of BaroStim device, with monitoring of pulmonary artery diastolic pressure, 6MWT, and vital signs
Follow-up
Participants are monitored for safety and effectiveness after BaroStim insertion
What Are the Treatments Tested in This Trial?
Interventions
- BaroStim
Trial Overview
The study tests the effectiveness of BaroStim in managing Heart Failure (HFrEF) by monitoring changes with CardioMems, which measures lung artery pressure. Patients will be observed for one year after receiving the BaroStim device.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
The intervention is insertion and titration of BaroStim. This is for patients with NYHA Class III heart failure who are candidates for CardioMems insertion (or have already received CardioMems in the past 3 months) and subsequent BaroStim insertion.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwell Health
Lead Sponsor
Citations
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 ...
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.
3.
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 ...
➢ These results were supported by objective evidence of significant reduction of NT-proBNP. ➢ BAT is equally safe and effective in patients with or without ...
Study Details | NCT07232030 | Barostim-Enabled ...
The purpose of BENEFIT-HF is to demonstrate the safety and effectiveness of Baroreflex Activation Therapy (BAT) with the Barostim System in ...
Real world evidence demonstrates significant reduction in ...
This analysis of a large all-payer database suggests that implantation of Barostim is associated with significant reductions in all-cause, cardiovascular, and ...
Important Safety & Regulatory Information
The Barostim System is indicated for patients who are NYHA Class III or Class II (who had a recent history of Class III) despite treatment with guideline- ...
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 ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.