Baroreflex Activation Therapy in Left Ventricular Assist Device Patients Study
NCT06195046 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2025-07-23
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
Interventions
- DEVICE
-
Baroreflex Activation Therapy (BAT)
activation of BAROSTIM NEO system that affects autonomic modulation with BAT therapy.
Sponsors & Collaborators
-
CVRx, Inc.
collaborator INDUSTRY -
Medical University of South Carolina
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-01
- Primary Completion
- 2025-07-01
- Completion
- 2025-07-01
- FDA Device
- Yes
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