NCT06195046

Brief Summary

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2025

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
1.5 years until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

Same day

First QC Date

July 21, 2023

Last Update Submit

July 18, 2025

Conditions

Congestive Heart Failure

Keywords

Ventricular Assist DeviceBaroreflex activation therapy

Outcome Measures

Primary Outcomes (1)

  • 6 Minute Hall Walk

    change in distance walked during 6 Minute Hall Walk

    3 months

Secondary Outcomes (13)

  • Minnesota Living with Heart Failure Questionnaire

    3 months, 6 months

  • Change in LVAD system monitor reported flow

    3 months, 6 months

  • Cardiac 123-mIBG scan

    3 months, 6 months

  • Change in left ventricular size on transthoracic echocardiogram

    3 months, 6 months

  • Change in aortic valve opening frequency on transthoracic echocardiogram

    3 months, 6 months

  • +8 more secondary outcomes

Study Arms (2)

control (BAT off)

SHAM COMPARATOR

Baroreflex activation therapy turned off for three months

Device: Baroreflex Activation Therapy (BAT)

treatment (BAT on)

EXPERIMENTAL

Baroreflex activation therapy turned on for three months

Device: Baroreflex Activation Therapy (BAT)

Interventions

Baroreflex Activation Therapy (BAT)DEVICE

activation of BAROSTIM NEO system that affects autonomic modulation with BAT therapy.

control (BAT off)treatment (BAT on)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • LVAD patient \> 3 months post implant
  • Existing BAT device

You may not qualify if:

  • Presence of cardiogenic shock, respiratory failure, hypotension or unstable heart failure
  • Bradycardia (resting HR \<60 beats/minute)
  • Presence of suspected pump thrombosis at the time of enrollment
  • Presence of any significant ventricular arrhythmias at the time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
patient and Investigator will not know whether the subject has BAT turned on or off during each of the 3 month follow-up intervals
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: double-blind cross-over study design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2023

First Posted

January 8, 2024

Study Start

July 1, 2025

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share