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OpenTrials
Completed

NCT Number: NCT06812975

Paceport Swan-Ganz Data Collection Study

In association with Edwards LifeSciences, the study will aim to develop an algorithm based on right heart (right atrial, right ventricular and pulmonary artery) waveforms for the early detection of RV dysfunction in cardiothoracic and liver surgery patients at UMMC. This is a prospective, non-interventional, observational study.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be ≥ 18 years of age presenting to the University of Minnesota Medical Center undergoing any cardiac surgery with cardiopulmonary bypass (CPB) or liver transplantation
  • Participate in the Informed Consent process and sign/date the approved informed consent forms
  • Projected to receive Swan-Ganz paceport catheter as part of procedure/standard of care with intermittent cardiac output and mixed venous oxygen saturation (SvO2) measures

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
  • Patients under the age of 18 years old
  • Patients with left bundle branch block, recurrent sepsis, or hypercoagulopathy
  • Patients allergic to FORE-SIGHT Elite sensor adhesive
  • Patients with latex allergy due to presence of latex in the Swan-Ganz catheter balloon.

Treatment and study plan

No intervention

Other

This is an observational study

Primary outcomes

  1. Arterial waveform

    Time frame: 24 hours postoperative

    The slope of the diastolic right ventricular waveform which includes measures of RV end-diastolic pressure and RV contractility (dPdt)

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Early Identification of Right Ventricular Dysfunction and Failure in Cardiothoracic and Liver Surgical Patients

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2025
Registry last updated
Aug 1, 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.

Published trials that share one or more normalized conditions with this study.