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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

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Completed

Conditions

Right Ventricular Dysfunction

Treatments

Diagnostic Test: Hemodynamic assessment

Study type

Observational

Funder types

Other

Identifiers

NCT04478890
ANES-2020-28725

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

4 participants in 1 patient group

Observational Group
Description:
Characterize right ventricular function while undergoing LVAD implantation
Treatment:
Diagnostic Test: Hemodynamic assessment

Trial contacts and locations

1

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Central trial contact

Tjorvi E Perry, MD, MMSc

Data sourced from clinicaltrials.gov

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