Baroreflex Activation Therapy for Heart Failure

(BAT-VAD Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Brian Houston

Disqualifiers: Cardiogenic shock, Respiratory failure, Hypotension, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study will involve LVAD patients who have already received a clinically-indicated BAT (BAROSTIM) device. After recovery from LVAD implant, we will investigate the effects of BAT in a double-blind cross-over study design.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Baroreflex Activation Therapy (BAT) for heart failure?

Research shows that Baroreflex Activation Therapy (BAT) can improve heart failure symptoms, reduce hospitalization rates, and enhance walking distance in patients with heart failure. It also helps in lowering blood pressure in patients with resistant hypertension, although more large-scale studies are needed to fully understand its long-term benefits and safety.

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Is Baroreflex Activation Therapy (BAT) safe for humans?

Baroreflex Activation Therapy (BAT) has been studied for conditions like resistant hypertension and heart failure. Some studies suggest it is safe and can improve symptoms, but large trials are still needed to fully understand its safety and effectiveness.

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How does baroreflex activation therapy differ from other treatments for heart failure?

Baroreflex activation therapy (BAT) is unique because it uses a device to electrically stimulate the carotid sinus, which helps balance the nervous system by reducing excessive sympathetic activity (part of the nervous system that can increase heart rate and blood pressure). Unlike traditional medications, BAT directly targets the autonomic nervous system to improve heart function and reduce symptoms in heart failure patients.

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Eligibility Criteria

This trial is for adults over 18 with heart failure who have had a left ventricular assist device (LVAD) implanted for at least 3 months and already have a BAROSTIM device. It's not suitable for those in shock, with severe breathing problems, very low blood pressure, slow heartbeat, suspected pump clotting or serious irregular heartbeats.

Inclusion Criteria

Existing BAT device

I am older than 18 years.

I have had my LVAD implant for more than 3 months.

Exclusion Criteria

I have severe heart or lung problems, like shock or unstable heart failure.

Bradycardia (resting HR <60 beats/minute)

Presence of suspected pump thrombosis at the time of enrollment

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment (BAT off)

Baroreflex activation therapy turned off for three months

3 months

Regular monitoring visits

Treatment (BAT on)

Baroreflex activation therapy turned on for three months

3 months

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Participant Groups

The study tests the effects of Baroreflex Activation Therapy (BAT) on patients with LVADs using a double-blind cross-over design. This means neither the researchers nor participants know when the BAT is active as they switch between 'on' and 'off' periods.

Group I: treatment (BAT on) Experimental Treatment 1 Intervention

Baroreflex activation therapy turned on for three months

Group II: control (BAT off) Placebo Group 1 Intervention

Baroreflex activation therapy turned off for three months

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Medical University of South Carolina Charleston, SC

Who Is Running the Clinical Trial?

Brian Houston Lead Sponsor

CVRx, Inc. Industry Sponsor

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Baroreflex activation therapy : Indication and evidence in resistant hypertension and heart failure]. [2019] Baroreflex activation therapy (BAT) is a sympathoinhibitory procedure for treatment of therapy-resistant hypertension (rsHTN) and severe heart failure with reduced ejection fraction (HFrEF) that been available for several years. The double-blind, randomized Rheos Pivotal Trial demonstrated a blood pressure lowering effect in patients with rsHTN for the first-generation BAT device. A smaller randomized study in heart failure showed that the Barostim Neo system is safe and can improve heart failure symptoms and decrease neuroendocrine activation. However, for this unilateral system, which is currently in clinical use, no data from large randomized trials exist. Despite existing data for BAT in rsHTN and HFrEF, large randomized trials, showing reduction of blood pressure and cardiovascular events are still lacking. Therefore, BAT's efficacy and safety cannot be conclusively assessed.

2. Netherlands pubmed.ncbi.nlm.nih.gov

Restoration of normal sympathetic neural function in heart failure following baroreflex activation therapy: final 43-month study report. [2018] Baroreflex activation therapy (BAT) exerts in severe heart failure sympathoinhibitory effects, improving clinical variables and reducing hospitalization rate. The current follow-up study was aimed at determining the long-term effects of BAT, assessing whether BAT in heart failure allows to restore physiological levels of sympathetic function.

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

Baroreflex activation therapy for the treatment of drug-resistant hypertension: new developments. [2021] In the past few years, novel accomplishments have been obtained in carotid baroreflex activation therapy (BAT) for the treatment of resistant hypertension. In addition, this field is still evolving with promising results in the reduction of blood pressure and heart rate. This overview addresses the latest developments in BAT for the treatment of drug-resistant hypertension. Although not totally understood considering the working mechanisms of BAT, it appeared to be possible to achieve at least as much efficacy of single-sided as bilateral stimulation. Therefore unlike the first-generation Rheos system, the second-generation Barostim neo operates by unilateral baroreflex activation, using a completely different carotid electrode. Also significant improvements in several cardiac parameters have been shown by BAT in hypertensive patients, which set the basis for further research to evaluate BAT as a therapy for systolic heart failure. Yet important uncertainties need to be clarified to guarantee beneficial effects; hence not all participants seem to respond to BAT.

4. England pubmed.ncbi.nlm.nih.gov

Baroreflex activation therapy in patients with heart failure with reduced ejection fraction: a single-centre experience. [2023] Heart failure with reduced ejection fraction (HFrEF) is associated with excessive sympathetic and impaired parasympathetic activity. The Barostim Neo™ device is used for electronical baroreflex activation therapy (BAT) to counteract autonomic nervous system dysbalance. Randomized trials have shown that BAT improves walking distance and reduces N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels at least in patients with only moderate elevation at baseline. Its impact on the risk of heart failure hospitalization (HFH) and death is not yet established, and experience in clinical routine is limited.

5. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term chronic baroreflex activation: persistent efficacy in patients with heart failure and reduced ejection fraction. [2019] Baroreflex activation therapy (BAT) has recently been shown to reduce muscle sympathetic nerve activity and hospitalization rate while improving clinical variables through 6 months of therapy in patients with heart failure and reduced ejection fraction (HFrEF). The objective of the present study is to extend the information on this patient cohort over a long-term follow-up.

6. England pubmed.ncbi.nlm.nih.gov

Chronic baroreflex activation effects on sympathetic nerve traffic, baroreflex function, and cardiac haemodynamics in heart failure: a proof-of-concept study. [2021] Heart failure (HF) pathophysiology is believed to be mediated by autonomic dysfunction, including chronic sympathoexcitation and diminished baroreflex sensitivity, which correlate with mortality risk. Baroreflex activation therapy (BAT) is a device-based treatment providing chronic baroreflex activation through electrical stimulation of the carotid sinus. BAT chronically reduces sympathetic activity in resistant hypertension. The purpose of this investigation is to determine BAT effects in clinical HF.