Hemodynamic Assessment of the Right Ventricle Using Pressure-volume Loop Catheter and Pulmonary Artery Catheter in Patients Undergoing Left Ventricular Assist Device Placement

Hemodynamic Assessment of the Right Ventricle Using Pressure-volume Loop Catheter and Pulmonary Artery Catheter in Patients Undergoing Left Ventricular Assist Device Placement at the University of Minnesota Medical Center

This study will include the placement of a pressure volume (PV) loop catheter in the right atrium of patients undergoing left ventricular assist device (LVAD) placement and measure relevant PV loop data. Transesophageal echocardiography (TEE) and pulmonary artery (PA) catheter parameters as comparators to the PV loop will be recorded.

Study Overview

• Status: Completed
• Conditions: Right Ventricular Dysfunction
• Intervention / Treatment: Diagnostic test: Hemodynamic assessment

Detailed Description

This will be a prospective observational study design to characterize right ventricular function in 5 consecutive patients undergoing LVAD implantation at the University of Minnesota Medical Center (UMMC). Pre-, intra- and postoperative care delivery to all enrolled and consented patients will meet the standards of care otherwise delivered to patients undergoing LVAD implantation at UMMC; care delivery will be at the discretion of the clinical care team and will not be altered based on the output of the right ventricular high-fidelity conductance catheters.

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All consecutive patients 18 years or older undergoing left ventricular assist device (LVAD) placement at the University of Minnesota Medical Center

Description

Inclusion Criteria:

- Patients undergoing left ventricular assist device (LVAD) placement at the University of Minnesota Medical Center

Exclusion Criteria:

• Patients with a history of internal jugular vein thrombosis or known reasons for not being able to thread a central venous catheter through either internal jugular vein
• Patients with a history of known esophageal strictures, esophageal or stomach cancer, esophageal varices, or any patient in whom a TEE is contraindicated
• Patients with permanent pacemakers whose right ventricle is being paced and not in normal sinus rhythm
• Patients unable to consent to participating in the study
• Patients who are pregnant will be excluded, as part of standard care, all female patients are screened for pregnancy prior to surgery.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational Group; Characterize right ventricular function while undergoing LVAD implantation	Diagnostic test: Hemodynamic assessment; Hemodynamic assessment of the right ventricle using pressure-volume loop catheter and pulmonary artery catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke volume	Stroke volume will be reported in units of millilitres per square metre	Approximately 4-6 hours
Heart rate	Heart rate will be reported in units of beats per minute	Approximately 4-6 hours
Ejection fraction	Ejection fraction will be reported as a percent	Approximately 4-6 hours
Cardiac output	Cardiac output will be reported in units of milliliters per minute	Approximately 4-6 hours
End-systolic pressure	End-systolic pressure will be reported in units of mmHG	Approximately 4-6 hours
End-systolic volume	End-systolic volume will be reported in units of milliliters	Approximately 4-6 hours
End-diastolic pressure	End-diastolic pressure will be reported in units of mmHG	Approximately 4-6 hours
End-diastolic volume	End-diastolic volume will be reported in units of milliliters	Approximately 4-6 hours
Right ventricular dP/dt	Right ventricular dP/dt will be reported in units of mmHg per second	Approximately 4-6 hours
Stroke work	Stroke work will be reported in units of gram meters (g*m)	Approximately 4-6 hours

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Tjorvi Perry, MD, MMSc, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Right
• Other Study ID Numbers: ANES-2020-28725

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No