What side effects are associated with this type of intervention?

Common treatments for heart failure include medications such as beta-blockers, ACE inhibitors, and diuretics, as well as device-based therapies like the Barostim System. Beta-blockers (e.g., metoprolol, carvedilol) can cause side effects such as fatigue, bradycardia, and hypotension. ACE inhibitors (e.g., ramipril) may lead to cough, hyperkalemia, and renal impairment. Diuretics can result in electrolyte imbalances and dehydration. The Barostim System, a form of Baroreceptor Activation Therapy, is being studied for its safety and effectiveness, with potential side effects including infection at the implant site, nerve damage, and device-related complications.

What prior FDA approvals exist?

The Barostim System, which involves baroreceptor activation therapy, is designed for patients with heart failure who remain symptomatic despite guideline-directed medical therapy. While specific FDA approvals for baroreceptor activation therapy are limited, other FDA-approved treatments for heart failure include medications such as beta-blockers, ACE inhibitors, ARBs, and newer agents like sacubitril/valsartan. Devices like implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (CRT) have also been approved to manage heart failure symptoms and improve patient outcomes.

What other types of research exist?

Promising novel alternatives to the Barostim System for heart failure patients include: 1) Tafamidis, which has shown efficacy in reducing mortality and cardiovascular-related hospitalizations in patients with transthyretin amyloid cardiomyopathy. 2) Vernakalant, which has been effective in the rapid conversion of recent-onset atrial fibrillation. 3) Diaphragm pacing, which has shown potential in improving respiratory function in patients with respiratory insufficiency due to conditions like amyotrophic lateral sclerosis. These alternatives offer different mechanisms of action and may be suitable for specific patient populations.

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Implantable Device

BATwire Implant Kit for Heart Failure

N/A

Waitlist Available

Research Sponsored by CVRx, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The artery planned for the Barostim implant must have no ulcerative carotid arterial plaques

The artery planned for the Barostim implant must have had no prior surgery, radiation, or endovascular stent placement in the carotid artery or the carotid sinus region

Must not have

Unable or unwilling to fulfill the protocol medication compliance and follow-up requirements

Baroreflex failure or autonomic neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months post implant

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, potential side effects may include typical surgical risks such as infection at the incision site, bleeding complications from the procedure itself or due to stopping antiplatelet drugs pre-surgery; there could also be device-specific issues like irritation or allergic reaction to materials (silicone/titanium) used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am between 21 and 80 years old.

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The artery for my Barostim implant is below my jawbone.

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I can stop taking blood thinners like aspirin before getting a Barostim implant.

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The artery for my Barostim implant does not have significant narrowing due to plaque.

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My medical history and condition are suitable for the Barostim System implant.

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My body's structure allows for safe implant surgery without any obstructions.

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I can walk between 150 and 400 meters in six minutes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have irregular, slow heartbeats that cause symptoms.

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I have a serious heart valve problem.

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I am currently receiving or will receive IV therapy to strengthen my heart's contractions.

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I have issues with my cranial nerves as found by an ENT exam.

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I currently have cancer.

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I have high blood pressure in the lungs.

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I have severe lung problems.

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My heart failure is due to a cause that can be treated or reversed.

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I have not had heart surgery in the last 3 months.

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I have not experienced sudden cardiac death within the last 3 months.

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I haven't had unstable chest pain in the last 3 months.

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I am undergoing or have undergone LVAD therapy or chronic dialysis.

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I do not have irregular heartbeats that are unpredictable.

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I have had an organ transplant or am being evaluated for one.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months post implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months post implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post implant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Freedom from Serious Adverse Events (SAEs) related to the implantation of the lead using the BATwire Implant Kit through 30 days post implant

Six Minute Hall Walk (6MHW)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: BATwire KitExperimental Treatment1 Intervention

Subjects will be implanted using the BATwire Implant Kit

0 / 25Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Barostim System, a form of Baroreceptor Activation Therapy (BAT), works by stimulating baroreceptors in the carotid artery, which helps to regulate blood pressure and heart function by activating the autonomic nervous system. This can lead to improved heart function and reduced symptoms in heart failure patients. Other common treatments include ACE inhibitors, which block the conversion of angiotensin I to angiotensin II, leading to vasodilation and reduced blood pressure; beta-blockers, which reduce heart rate and myocardial oxygen demand by blocking the effects of adrenaline; and diuretics, which help to remove excess fluid from the body, reducing the workload on the heart. These treatments are crucial for managing heart failure as they help to improve cardiac output, reduce symptoms, and enhance the quality of life for patients.