An interventional study of Standardized RV Management and Usual Care RV Management in Heart Failure, Right Ventricular Dysfunction and Right Ventricular Failure, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-16.
Sponsored by University of Chicago · Not applicable, Interventional, and Treatment
This project evaluates right ventricle (RV) protective strategies after left ventricular assist device (LVAD) implantation.
The main purpose of this study is to learn more about protecting against RV dysfunction and RV failure (RVF) in patients receiving LVAD implantations.
This is a prospective, randomized controlled study that will include 20 patients with heart failure undergoing LVAD implantation. Patients will receive their LVAD implantation as part of routine care. Patients will be randomized 1:1 to one of two arms, 1) standardized RV management arm, and 2) usual care RV management arm, which are both consistent with standard of care (SOC).
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 20 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Physicians will follow prespecified parameters for RV management (consistent with SOC)
Other: Standardized RV Management
Physicians will use their own clinical judgement with no prespecified goals for RV management parameters (consistent with SOC)
Other: Usual Care RV Management
Standardized parameters for post-operative management (i.e., Rhythm Management, Ventilation Management, RV Ischemia Management, RV Preload, RV Afterload, RV Contractility, and RV Geometry)
No standardized parameters for post-operative management (i.e., Rhythm Management, Ventilation Management, RV Ischemia Management, RV Preload, RV Afterload, RV Contractility, and RV Geometry)
Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 3
RAP measured by pulmonary artery catheter
Time frame: Baseline, Day 3
Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 7
RAP measured by pulmonary artery catheter
Time frame: Baseline, Day 7
Change in right atrial pressure (RAP) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
RAP measured by pulmonary artery catheter
Time frame: Baseline, end of hemodynamic monitoring (about Day 10)
Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to post-operative day 3
RAP/PCWP measured by pulmonary artery catheter
Time frame: Baseline, Day 3
Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to post-operative day 7
RAP/PCWP measured by pulmonary artery catheter
Time frame: Baseline, Day 7
Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
RAP/PCWP measured by pulmonary artery catheter
Time frame: Baseline, end of hemodynamic monitoring (about Day 10)
Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 3
PAPI measured by pulmonary artery catheter
Time frame: Baseline, Day 3
Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 7
PAPI measured by pulmonary artery catheter
Time frame: Baseline, Day 7
Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
PAPI measured by pulmonary artery catheter
Time frame: Baseline, end of hemodynamic monitoring (about Day 10)
Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to post-operative day 3
RVSWI measured by pulmonary artery catheter
Time frame: Baseline, Day 3
Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to post-operative day 7
RVSWI measured by pulmonary artery catheter
Time frame: Baseline, Day 7
Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
RVSWI measured by pulmonary artery catheter
Time frame: Baseline, end of hemodynamic monitoring (about Day 10)
Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 3
CPO measured by pulmonary artery catheter
Time frame: Baseline, Day 3
Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 7
CPO measured by pulmonary artery catheter
Time frame: Baseline, Day 7
Change in cardiac power output (CPO) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
CPO measured by pulmonary artery catheter
Time frame: Baseline, end of hemodynamic monitoring (about Day 10)
RV failure defined by the 2014 Interagency Registry for Mechanical Circulatory Support (INTERMACS)
The INTERMACS definition of RVF stratifies patients based on duration of inotropic therapy, inhaled nitric oxide therapy, vasodilator therapy or RVAD implantation. RVF is described as mild, moderate, severe, or severe acute based on ≤7, 8-14, \>14 days of the above therapies or RVAD implantation, respectively
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
RV failure defined by the 2020 Academic Research Consortium (ARC)
The ARC definition of RVF stratifies patients based on the onset of RVF (e.g. early acute right heart failure, early post-implant right heart failure, or late right heart failure) requiring inotropic therapy or RVAD implantation during LVAD implantation, \<30 days post-operatively, or \>30 days post-operatively, respectively
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Inotropic therapy
Total number of inotropes used
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Vasopressor therapy
Total number of vasopressors used
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Total time on inhaled nitric oxide
Measured in days
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Number of individuals who experience all-cause mortality
All-cause mortality
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
ICU length of stay
Measured in days
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Hospital length of stay
Measured in days
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Number of individuals with acute kidney injuries requiring renal replacement therapy
Acute kidney injury requiring renal replacement therapy (intermittent hemodialysis or continuous renal replacement therapy)
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Number of individuals with transient ischemic attacks [TIA] or cerebrovascular accidents [CVA]
Transient ischemic attack or cerebrovascular accident as diagnosed by a Neurologist either clinically and/or radiographically
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Number of individuals with an arrhythmia requiring medical team intervention
Arrhythmia requiring medical team intervention, either through electrical or chemical cardioversion or any intravenous anti-arrhythmia medication administration
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Number of individuals who need tracheostomy
Need for tracheostomy
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Number of individuals needing percutaneous endoscopic gastrostomy tube
Need for percutaneous endoscopic gastrostomy tube
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Plan to share: No
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This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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