Mitigating Post-Op RV Dysfunction After LVAD Implantation

University of Chicago20 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure Right Ventricular Dysfunction Right Ventricular Failure

Interventions

Standardized RV ManagementOTHER

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 ManagementOTHER

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

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