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Completed

NCT Number: NCT05758194

Mitigating Post-Op RV Dysfunction After LVAD Implantation

This project evaluates right ventricle (RV) protective strategies after left ventricular assist device (LVAD) implantation.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Right Ventricular Dysfunction Right Ventricular Failure Ventricular Dysfunction Ventricular Dysfunction, Right

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standardized RV Management

Other

Standardized parameters for post-operative management (i.e., Rhythm Management, Ventilation Management, RV Ischemia Management, RV Preload, RV Afterload, RV Contractility, and RV Geometry)

Usual Care RV Management

Other

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)

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

Secondary outcomes

  1. RV failure defined by the 2014 Interagency Registry for Mechanical Circulatory Support (INTERMACS)

    Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation

    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

  2. RV failure defined by the 2020 Academic Research Consortium (ARC)

    Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation

    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

  3. Inotropic therapy

    Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation

    Total number of inotropes used

  4. Vasopressor therapy

    Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation

    Total number of vasopressors used

  5. Total time on inhaled nitric oxide

    Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation

    Measured in days

  6. Number of individuals who experience all-cause mortality

    Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation

    All-cause mortality

  7. ICU length of stay

    Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation

    Measured in days

  8. Hospital length of stay

    Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation

    Measured in days

  9. Number of individuals with acute kidney injuries requiring renal replacement therapy

    Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation

    Acute kidney injury requiring renal replacement therapy (intermittent hemodialysis or continuous renal replacement therapy)

  10. Number of individuals with transient ischemic attacks [TIA] or cerebrovascular accidents [CVA]

    Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation

    Transient ischemic attack or cerebrovascular accident as diagnosed by a Neurologist either clinically and/or radiographically

  11. Number of individuals with an arrhythmia requiring medical team intervention

    Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation

    Arrhythmia requiring medical team intervention, either through electrical or chemical cardioversion or any intravenous anti-arrhythmia medication administration

  12. Number of individuals who need tracheostomy

    Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation

    Need for tracheostomy

  13. Number of individuals needing percutaneous endoscopic gastrostomy tube

    Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation

    Need for percutaneous endoscopic gastrostomy tube

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Protective Strategies to Mitigate Post-Operative Right Ventricular (PV) Dysfunction After Centrifugal Flow Durable Left Ventricular Assist Device (LVAD) Implantation

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Mar 7, 2023
Registry last updated
Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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