RECRUITING
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Baroreflex Activation Therapy in Left Ventricular Assist Device Patients Study
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 Start (Actual) 1 February 2024
🗓️ Primary Completion (Estimated) 25 April 2026
✅ Study Completion (Estimated) 25 April 2027
👥 Enrollment (Estimated) 10
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Charleston, South Carolina, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 21 July 2023
  • First Submitted that Met QC Criteria 5 January 2024
  • First Posted 8 January 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 January 2024
  • Last Update Posted 8 January 2024
  • Last Verified January 2024
I'm interested ...!!