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Baroreflex Activation Therapy for Heart Failure (BAT-VAD Trial)

N/A
Recruiting
Research Sponsored by Brian Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years
Be older than 18 years old
Must not have
Presence of cardiogenic shock, respiratory failure, hypotension or unstable heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months
Awards & highlights

Summary

This trial will study the effects of a device called BAT (BAROSTIM) in patients who have already received a LVAD (Left Ventricular Assist Device). The study will be done in a double

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, generally BAT can cause changes in blood pressure or heart rate. Side effects may vary based on individual health conditions and how one's body reacts to therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe heart or lung problems, like shock or unstable heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
6 Minute Hall Walk
Secondary study objectives
Cardiac 123-mIBG scan
Change in LVAD system monitor reported flow
Change in Serum catecholamines
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: treatment (BAT on)Experimental Treatment1 Intervention
Baroreflex activation therapy turned on for three months
Group II: control (BAT off)Placebo Group1 Intervention
Baroreflex activation therapy turned off for three months

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Who is running the clinical trial?

CVRx, Inc.Industry Sponsor
20 Previous Clinical Trials
8,521 Total Patients Enrolled
Brian HoustonLead Sponsor
~7 spots leftby Apr 2026
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