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

Right Ventricular Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04478890
• Other study ID #: ANES-2020-28725
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2024
• Source: University of Minnesota
• Contact: Tjorvi E Perry, MD, MMSc
• Phone: 6124027900
• Email: perry655[@]umn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

Diagnostic Test:
• Hemodynamic assessment
Hemodynamic assessment of the right ventricle using pressure-volume loop catheter and pulmonary artery catheter

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

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