NCT05758194

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

March 22, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2025

Completed
Last Updated

October 16, 2025

Status Verified

October 1, 2025

Enrollment Period

1.8 years

First QC Date

February 24, 2023

Last Update Submit

October 14, 2025

Conditions

Heart FailureRight Ventricular DysfunctionRight Ventricular Failure

Keywords

LVADLVAD-related complicationsright ventricular dysfunctionhemocompatibility-related adverse eventshemodynamic-related eventspost-operative right ventricular managementright ventricular failure

Outcome Measures

Primary Outcomes (15)

  • Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 3

    RAP measured by pulmonary artery catheter

    Baseline, Day 3

  • Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 7

    RAP measured by pulmonary artery catheter

    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

    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

    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

    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

    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

    Baseline, Day 3

  • Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 7

    PAPI measured by pulmonary artery catheter

    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

    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

    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

    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

    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

    Baseline, Day 3

  • Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 7

    CPO measured by pulmonary artery catheter

    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

    Baseline, end of hemodynamic monitoring (about Day 10)

Secondary Outcomes (13)

  • 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

  • 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

  • Total time on inhaled nitric oxide

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

  • +8 more secondary outcomes

Study Arms (2)

Standardized RV Management

ACTIVE COMPARATOR

Physicians will follow prespecified parameters for RV management (consistent with SOC)

Other: Standardized RV Management

Usual Care RV Management

ACTIVE COMPARATOR

Physicians will use their own clinical judgement with no prespecified goals for RV management parameters (consistent with SOC)

Other: Usual Care RV Management

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)

Standardized RV Management
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)

Usual Care RV Management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Undergoing durable LVAD implantation without plan for perioperative right ventricular mechanical circulatory support

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Heart FailureVentricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVentricular Dysfunction

Study Officials

  • Jonathan Grinstein, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2023

First Posted

March 7, 2023

Study Start

March 22, 2023

Primary Completion

December 31, 2024

Study Completion

March 28, 2025

Last Updated

October 16, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)