BATwire Implant Kit for Heart Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new procedure called the BATwire Implant Kit, designed to help people with heart failure who continue to experience symptoms despite standard medical treatments. The researchers aim to determine the safety and effectiveness of this procedure. It may suit those with heart failure symptoms, a specific heart condition (NYHA Class II or III), and who have not benefited from other specific heart therapies. Participants should not have undergone certain heart surgeries or therapies recently. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for heart failure.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but you must be able to stop using antiplatelet drugs (like aspirin) if required before the procedure.
What prior data suggests that the BATwire Implant Kit is safe for heart failure patients?
Research shows that the Barostim System, used with the BATwire Implant Kit, could be a safe option for people with heart failure who don't respond to standard treatments. The FDA has already approved the Barostim System for certain heart conditions, suggesting a degree of safety. For heart failure patients, this device has helped improve well-being and reduced hospital visits.
However, specific information about side effects or problems from using the BATwire Implant Kit in current studies isn't clearly available. Since the trial is in an early phase, detailed safety information might not be fully established yet. Nonetheless, the existing approval of the Barostim System for other conditions provides some reassurance about its safety. Consulting a healthcare provider is always advisable to understand what this might mean for one's health.12345Why are researchers excited about this trial?
The BATwire Implant Kit is unique because it offers a novel approach to treating heart failure by directly targeting the autonomic nervous system. Unlike standard treatments like beta-blockers, ACE inhibitors, or pacemakers, which manage symptoms or regulate heart rhythms, the BATwire Implant Kit uses a minimally invasive implant to modulate nerve signals and potentially improve heart function directly. Researchers are excited about this treatment because it could provide a more direct and potentially faster way to improve heart health in patients with heart failure, offering hope for those who may not respond well to existing therapies.
What evidence suggests that the BATwire Implant Kit is effective for heart failure?
Research has shown that the Barostim System, used with the BATwire Implant Kit, effectively treats heart failure. Studies have found that baroreflex activation therapy (BAT), the process used by the Barostim System, is safe and can improve symptoms for patients with heart failure who have a reduced ejection fraction (HFrEF). Patients report a better quality of life and less congestion. This treatment benefits those who do not respond to standard treatments. Overall, evidence supports the Barostim System as an effective option for managing heart failure symptoms.12567
Who Is on the Research Team?
Bradley Knight, MD
Principal Investigator
Northwestern University
Michael Zile, MD
Principal Investigator
Medical University of South Carolina
Fred Weaver, MD
Principal Investigator
University of Southern California
Are You a Good Fit for This Trial?
Adults aged 21-80 with heart failure, who are symptomatic despite treatment, have an ejection fraction ≤35%, NT-proBNP <1600 pg/ml, and aren't candidates for Cardiac Resynchronization Therapy. They must be suitable for surgery based on medical history and tests like CDU or CTA, have specific artery conditions for the implant, can stop certain drugs if needed before the procedure, use birth control if applicable, meet Barostim's usage criteria after screening and baseline assessments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Implantation
Subjects are implanted with the Barostim System using the BATwire Kit and the device is activated prior to discharge
Follow-up
Participants are monitored for safety and effectiveness after implantation with follow-up visits at 0.5, 1, 2, 3, 6, and 12 months post implant
What Are the Treatments Tested in This Trial?
Interventions
- BATwire Implant Kit
Find a Clinic Near You
Who Is Running the Clinical Trial?
CVRx, Inc.
Lead Sponsor