Status:
WITHDRAWN
Baroreflex Activation Therapy in Left Ventricular Assist Device Patients Study
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
CVRx, Inc.
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
Left ventricular assist devices (LVADs) provide a meaningful therapeutic option for patients with end-stage systolic heart failure who cannot receive cardiac transplantation. For these patients, LVADs...
Eligibility Criteria
Inclusion
- Age \> 18 years
- LVAD patient \> 3 months post implant
- Existing BAT device
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06195046
Start Date
July 1 2025
End Date
July 1 2025
Last Update
July 23 2025
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