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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Right Ventricular Dysfunction

Intervention / Treatment
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* Diagnostic Test: Hemodynamic assessment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational Group<br>Characterize right ventricular function while undergoing LVAD implantation | Diagnostic Test: Hemodynamic assessment<br>* Hemodynamic assessment of the right ventricle using pressure-volume loop catheter and pulmonary artery catheter<br>|

What is the study measuring?
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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 |