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

NCT04478890 | Completed DMC

• 1 other identifier: ANES-2020-28725
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Right Ventricular Dysfunction

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (1)

Observational Group

Characterize right ventricular function while undergoing LVAD implantation

Diagnostic Test: Hemodynamic assessment

Interventions

Hemodynamic assessment DIAGNOSTIC_TEST

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

Observational Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive patients 18 years or older undergoing left ventricular assist device (LVAD) placement at the University of Minnesota Medical Center

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Tjorvi Perry, MD, MMSc

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 21, 2020
• Study Start: August 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-02

Locations

US (1)