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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04478890
Enrollment
4
Registered
2020-07-21
Start date
2021-08-01
Completion date
2024-12-31
Last updated
2025-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Right Ventricular Dysfunction

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.

Interventions

DIAGNOSTIC_TESTHemodynamic assessment

Hemodynamic assessment of the right ventricle using pressure-volume loop catheter and pulmonary artery catheter

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
End-diastolic pressureApproximately 4-6 hoursEnd-diastolic pressure will be reported in units of mmHG
End-diastolic volumeApproximately 4-6 hoursEnd-diastolic volume will be reported in units of milliliters
Right ventricular dP/dtApproximately 4-6 hoursRight ventricular dP/dt will be reported in units of mmHg per second
Stroke volumeApproximately 4-6 hoursStroke volume will be reported in units of millilitres per square metre
Heart rateApproximately 4-6 hoursHeart rate will be reported in units of beats per minute
Ejection fractionApproximately 4-6 hoursEjection fraction will be reported as a percent
Cardiac outputApproximately 4-6 hoursCardiac output will be reported in units of milliliters per minute
End-systolic pressureApproximately 4-6 hoursEnd-systolic pressure will be reported in units of mmHG
End-systolic volumeApproximately 4-6 hoursEnd-systolic volume will be reported in units of milliliters
Stroke workApproximately 4-6 hoursStroke work will be reported in units of gram meters (g\*m)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026