Protective Strategies to Mitigate Post-Operative Right Ventricular (PV) Dysfunction After Centrifugal Flow Durable Left Ventricular Assist Device (LVAD) Implantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Chicago
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 3
Study Overview
Brief Summary
This project evaluates right ventricle (RV) protective strategies after left ventricular assist device (LVAD) implantation.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •Undergoing durable LVAD implantation without plan for perioperative right ventricular mechanical circulatory support
Exclusion Criteria
- •Patients with pre-operative right ventricular mechanical circulatory support or having high likelihood of requiring right ventricular mechanical circulatory support.
- •Patients with RV implantable cardiac device (ICD)/pacemaker lead who are pacemaker-dependent
- •Pregnant patients
Outcomes
Primary Outcomes
Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 3
Time Frame: Baseline, Day 3
RAP measured by pulmonary artery catheter
Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 7
Time Frame: Baseline, Day 7
RAP measured by pulmonary artery catheter
Change in right atrial pressure (RAP) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
Time Frame: Baseline, end of hemodynamic monitoring (about Day 10)
RAP measured by pulmonary artery catheter
Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to post-operative day 3
Time Frame: Baseline, Day 3
RAP/PCWP measured by pulmonary artery catheter
Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to post-operative day 7
Time Frame: Baseline, Day 7
RAP/PCWP measured by pulmonary artery catheter
Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 3
Time Frame: Baseline, Day 3
PAPI measured by pulmonary artery catheter
Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
Time Frame: Baseline, end of hemodynamic monitoring (about Day 10)
PAPI measured by pulmonary artery catheter
Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to post-operative day 3
Time Frame: Baseline, Day 3
RVSWI measured by pulmonary artery catheter
Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to post-operative day 7
Time Frame: Baseline, Day 7
RVSWI measured by pulmonary artery catheter
Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
Time Frame: Baseline, end of hemodynamic monitoring (about Day 10)
RAP/PCWP measured by pulmonary artery catheter
Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 7
Time Frame: Baseline, Day 7
PAPI measured by pulmonary artery catheter
Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
Time Frame: Baseline, end of hemodynamic monitoring (about Day 10)
RVSWI measured by pulmonary artery catheter
Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 3
Time Frame: Baseline, Day 3
CPO measured by pulmonary artery catheter
Change in cardiac power output (CPO) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
Time Frame: Baseline, end of hemodynamic monitoring (about Day 10)
CPO measured by pulmonary artery catheter
Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 7
Time Frame: Baseline, Day 7
CPO measured by pulmonary artery catheter
Secondary Outcomes
- Inotropic therapy(Through duration of hospitalization, up to 30 days following LVAD implantation)
- Vasopressor therapy(Through duration of hospitalization, up to 30 days following LVAD implantation)
- RV failure defined by the 2014 Interagency Registry for Mechanical Circulatory Support (INTERMACS)(Through duration of hospitalization, up to 30 days following LVAD implantation)
- RV failure defined by the 2020 Academic Research Consortium (ARC)(Through duration of hospitalization, up to 30 days following LVAD implantation)
- Total time on inhaled nitric oxide(Through duration of hospitalization, up to 30 days following LVAD implantation)
- Number of individuals who experience all-cause mortality(Through duration of hospitalization, up to 30 days following LVAD implantation)
- Number of individuals with an arrhythmia requiring medical team intervention(Through duration of hospitalization, up to 30 days following LVAD implantation)
- Number of individuals who need tracheostomy(Through duration of hospitalization, up to 30 days following LVAD implantation)
- ICU length of stay(Through duration of hospitalization, up to 30 days following LVAD implantation)
- Hospital length of stay(Through duration of hospitalization, up to 30 days following LVAD implantation)
- Number of individuals with acute kidney injuries requiring renal replacement therapy(Through duration of hospitalization, up to 30 days following LVAD implantation)
- Number of individuals with transient ischemic attacks [TIA] or cerebrovascular accidents [CVA](Through duration of hospitalization, up to 30 days following LVAD implantation)
- Number of individuals needing percutaneous endoscopic gastrostomy tube(Through duration of hospitalization, up to 30 days following LVAD implantation)