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

Last updated: February 3, 2025
Sponsor: University of Minnesota
Overall Status: Completed

Phase

N/A

Condition

Heart Failure

Treatment

Hemodynamic assessment

Clinical Study ID

NCT04478890
ANES-2020-28725
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients undergoing left ventricular assist device (LVAD) placement at theUniversity of Minnesota Medical Center

Exclusion

Exclusion Criteria:

  • Patients with a history of internal jugular vein thrombosis or known reasons for notbeing able to thread a central venous catheter through either internal jugular vein

  • Patients with a history of known esophageal strictures, esophageal or stomachcancer, esophageal varices, or any patient in whom a TEE is contraindicated

  • Patients with permanent pacemakers whose right ventricle is being paced and not innormal sinus rhythm

  • Patients unable to consent to participating in the study

  • Patients who are pregnant will be excluded, as part of standard care, all femalepatients are screened for pregnancy prior to surgery.

Study Design

Total Participants: 4
Treatment Group(s): 1
Primary Treatment: Hemodynamic assessment
Phase:
Study Start date:
August 01, 2021
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

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