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Clinical Trials/NCT04478890
NCT04478890
Completed
Not Applicable

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

University of Minnesota1 site in 1 country4 target enrollmentAugust 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Right Ventricular Dysfunction
Sponsor
University of Minnesota
Enrollment
4
Locations
1
Primary Endpoint
End-diastolic pressure
Status
Completed
Last Updated
last year

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
December 31, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

End-diastolic pressure

Time Frame: Approximately 4-6 hours

End-diastolic pressure will be reported in units of mmHG

End-diastolic volume

Time Frame: Approximately 4-6 hours

End-diastolic volume will be reported in units of milliliters

Stroke work

Time Frame: Approximately 4-6 hours

Stroke work will be reported in units of gram meters (g\*m)

Stroke volume

Time Frame: Approximately 4-6 hours

Stroke volume will be reported in units of millilitres per square metre

End-systolic pressure

Time Frame: Approximately 4-6 hours

End-systolic pressure will be reported in units of mmHG

End-systolic volume

Time Frame: Approximately 4-6 hours

End-systolic volume will be reported in units of milliliters

Heart rate

Time Frame: Approximately 4-6 hours

Heart rate will be reported in units of beats per minute

Ejection fraction

Time Frame: Approximately 4-6 hours

Ejection fraction will be reported as a percent

Cardiac output

Time Frame: Approximately 4-6 hours

Cardiac output will be reported in units of milliliters per minute

Right ventricular dP/dt

Time Frame: Approximately 4-6 hours

Right ventricular dP/dt will be reported in units of mmHg per second

Study Sites (1)

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