Recruiting

Baroreflex Activation

Sponsor:

Brian Houston

Code:

NCT06195046

Conditions

Congestive Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Baroreflex Activation Therapy (BAT)

Study Details

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.

Conditions

Congestive Heart Failure

Study ID

NCT06195046

Start date

Feb 1, 2025

Status verified date

Apr, 2024

Completion date

Apr 25, 2027

Anticipated

Primary completion date

Apr 25, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

sham comparator: control (BAT off)

Baroreflex activation therapy turned off for three months

experimental: treatment (BAT on)

Baroreflex activation therapy turned on for three months

Interventions

Baroreflex Activation Therapy (BAT)

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

Primary outcome measure

  • 6 Minute Hall Walk [ Time Frame: 3 months ]

Central Contacts and Locations

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Renee L Baxley, BS

843-792-1105baxleyr@musc.edu

More Information

Sponsor

Brian Houston

Last update posted

Dec 17, 2024

Last verified

Apr, 2024

Keywords

  • Ventricular Assist Device
  • Baroreflex activation therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brian Houston on 2024-12-17.