TARGET-LOAD Pilot Study Comparing Hemodynamics-guided LVAD Unloading Vs. Standard of Care
NCT04977310 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2024-12-16
Summary
This study is a prospective, randomized-controlled, non-blinded, multi-center, pilot trial to compare standard-of-care left ventricular assist device (LVAD) unloading plus heart failure (HF) medications reverse-remodeling management versus hemodynamics-guided LVAD unloading with use of the wireless monitoring system CardioMEMS plus HF medications reverse-remodeling management.
Conditions
Interventions
- DEVICE
-
CardioMEMS
Cardio-MEMS-guided Post-LVAD cardiac unloading and recovery
Sponsors & Collaborators
- collaborator INDUSTRY
-
STAVROS G DRAKOS
lead OTHER
Principal Investigators
-
Stavros Drakos, M.D. · University of Utah
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-31
- Primary Completion
- 2026-09-01
- Completion
- 2026-09-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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