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treatment (BAT on) for Congestive 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months

Awards & highlights

BAT-VAD Trial 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.Check my eligibility

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.See study design

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.

BAT-VAD Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am older than 18 years.

BAT-VAD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

6 Minute Hall Walk

Secondary outcome measures

Cardiac 123-mIBG scan

Change in LVAD system monitor reported flow

Change in Serum catecholamines

+10 more

BAT-VAD 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

CVRx, Inc.Industry Sponsor

20 Previous Clinical Trials

8,828 Total Patients Enrolled

Brian HoustonLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being recruited for this clinical trial at the moment?

"Indeed, as per the information available on clinicaltrials.gov, this study is actively seeking eligible patients. The trial was initially posted on February 1st, 2024 and its most recent update occurred on January 5th, 2024."

Answered by AI

What is the current number of subjects enrolled in this medical study?

"Indeed, as per the details provided on clinicaltrials.gov, this trial is currently seeking suitable candidates. The initial posting of the trial was on February 1st, 2024 and it was most recently updated on January 5th, 2024. The study aims to enroll a total of 10 participants from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Baroreflex Activation Therapy in Left Ventricular Assist Device Patients Study

Brian Houston 2024. "Baroreflex Activation Therapy in Left Ventricular Assist Device Patients Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06195046.

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