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Completed

NCT Number: NCT04478890

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

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.

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Key information

Conditions

Right Ventricular Dysfunction Cardiovascular Diseases Heart Diseases Ventricular Dysfunction Ventricular Dysfunction, Right

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hemodynamic assessment

Diagnostic Test

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

Primary outcomes

  1. Stroke volume

    Time frame: Approximately 4-6 hours

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

  2. Heart rate

    Time frame: Approximately 4-6 hours

    Heart rate will be reported in units of beats per minute

  3. Ejection fraction

    Time frame: Approximately 4-6 hours

    Ejection fraction will be reported as a percent

  4. Cardiac output

    Time frame: Approximately 4-6 hours

    Cardiac output will be reported in units of milliliters per minute

  5. End-systolic pressure

    Time frame: Approximately 4-6 hours

    End-systolic pressure will be reported in units of mmHG

  6. End-systolic volume

    Time frame: Approximately 4-6 hours

    End-systolic volume will be reported in units of milliliters

  7. End-diastolic pressure

    Time frame: Approximately 4-6 hours

    End-diastolic pressure will be reported in units of mmHG

  8. End-diastolic volume

    Time frame: Approximately 4-6 hours

    End-diastolic volume will be reported in units of milliliters

  9. Right ventricular dP/dt

    Time frame: Approximately 4-6 hours

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

  10. Stroke work

    Time frame: Approximately 4-6 hours

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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2020
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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