BATwire Implant Kit for Heart Failure

Recruiting at 11 trial locations

Overseen By Elizabeth Galle

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CVRx, Inc.

Must not be taking: Antiplatelet drugs

Disqualifiers: CRT, Unstable arrhythmias, COPD, others

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

Compensation: Varies

Number of Visits: 7

93 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a device called the Barostim System, implanted using the BATwire Kit, in heart failure patients who don't respond to standard treatments. The device sends electrical signals to help the heart work better and reduce symptoms. Baroreflex activation therapy (BAT) has been studied for its safety and efficacy in heart failure patients, often in combination with other devices like ICDs.

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 data supports the effectiveness of the BATwire Implant Kit treatment for heart failure?

Research shows that baroreflex activation therapy (BAT), which is part of the BATwire Implant Kit, significantly improves heart failure symptoms, quality of life, and exercise capacity in patients with heart failure with reduced ejection fraction. The treatment is safe and its benefits are maintained for at least one year. ^{1 2 3 4 5}

What safety data exists for the BATwire Implant Kit for Heart Failure?

The research highlights the importance of robust postmarket surveillance systems for cardiac implantable devices to ensure patient safety and reduce harm. It also discusses the challenges in reporting and managing device-related issues, emphasizing the need for improved methods to identify and respond to safety signals. ^{6 7 8 9 10}

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

Eligibility Criteria

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

The artery for my Barostim implant does not have ulcerative plaques.

The artery for my Barostim implant has had no previous surgery, radiation, or stents.

At the end of screening and baseline, the subject still meets the Barostim Indication for Use

Exclusion Criteria

I cannot or do not want to follow the study's medication and check-up schedule.

I had a heart procedure like stenting or bypass surgery within the last 3 months.

I have a condition affecting my body's ability to control blood pressure or nerve function.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Subjects are implanted with the Barostim System using the BATwire Kit and the device is activated prior to discharge

1 week

1 visit (in-person)

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

12 months

6 visits (in-person)

Treatment Details

Interventions

• BATwire Implant Kit

Trial Overview The BATwire Implant Kit is being tested to see if it's safe and effective in patients with heart failure. The trial involves surgically implanting the Barostim System using this kit to help manage symptoms of heart failure in those who haven't improved sufficiently with standard treatments.

Participant Groups

Group I: BATwire Kit Experimental Treatment 1 Intervention

Subjects will be implanted using the BATwire Implant Kit

Who Is Running the Clinical Trial?

CVRx, Inc.

Lead Sponsor

Trials

21

Recruited

8,500+

Findings from Research

The article highlights the challenges medical device companies face in deciding whether to report adverse events related to device implants to regulatory authorities.

It discusses UK vigilance guidance documents that provide a framework to help manufacturers make informed decisions about reporting, which can enhance safety and accountability in the medical device industry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dilemma of reporting device-related adverse events. Donawa, M.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

Surgical Experience and Long-term Results of Baroreflex Activation Therapy for Heart Failure With Reduced Ejection Fraction. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Prospective evaluation of elastic restraint to lessen the effects of heart failure (PEERLESS-HF) trial. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Rationale and design of the AdaptResponse trial: a prospective randomized study of cardiac resynchronization therapy with preferential adaptive left ventricular-only pacing. [2018]

4. China pubmed.ncbi.nlm.nih.gov

[New Technologies and Devices of Heart Failure with Reduced Ejection Fraction]. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Chronic baroreflex activation: a potential therapeutic approach to heart failure with preserved ejection fraction. [2011]

6. United States pubmed.ncbi.nlm.nih.gov

The dilemma of reporting device-related adverse events. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Sensing/pacing lead complications with a newer generation implantable cardioverter-defibrillator: worldwide experience from the Guardian ATP 4210 clinical trial. [2019]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Global Landscape of Benefit-Risk Considerations for Medicinal Products: Current State and Future Directions. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Postmarket surveillance of medical devices: current capabilities and future opportunities. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Focus on management of pacemaker and ICD advisories, recalls, and alerts. [2020]