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

Recruiting

• Conditions: Right Ventricular Dysfunction
• Interventions: Diagnostic Test: Hemodynamic assessment

• Registration Number: NCT04478890
• Lead Sponsor: University of Minnesota

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-21
• Study Start: 2021-08-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-14
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational Group	Hemodynamic assessment	Characterize right ventricular function while undergoing LVAD implantation

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States