Paceport Swan-Ganz Data Collection Study

July 31, 2025 updated by: University of Minnesota

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

≥ 18 years of age presenting to the University of Minnesota Medical Center undergoing any cardiac surgery with cardiopulmonary bypass (CPB) or liver transplantation

Description

Inclusion Criteria:

  1. Be ≥ 18 years of age presenting to the University of Minnesota Medical Center undergoing any cardiac surgery with cardiopulmonary bypass (CPB) or liver transplantation
  2. Participate in the Informed Consent process and sign/date the approved informed consent forms
  3. 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:

  1. 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
  2. Patients with a history of known esophageal strictures, esophageal or stomach cancer, esophageal varices, or any patient in whom a TEE is contraindicated
  3. Patients with permanent pacemakers whose right ventricle is being paced and not in normal sinus rhythm
  4. Patients unable to consent to participating in the study
  5. Patients who are pregnant will be excluded, as part of standard care, all female patients are screened for pregnancy prior to surgery
  6. Patients under the age of 18 years old
  7. Patients with left bundle branch block, recurrent sepsis, or hypercoagulopathy
  8. Patients allergic to FORE-SIGHT Elite sensor adhesive
  9. Patients with latex allergy due to presence of latex in the Swan-Ganz catheter balloon.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
undergoing any cardiac surgery with cardiopulmonary bypass (CPB) or liver transplantation
Other: No intervention
This is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Tjorvi E Perry, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2021

Primary Completion (Actual)

July 8, 2025

Study Completion (Actual)

July 8, 2025

Study Registration Dates

First Submitted

February 2, 2025

First Submitted That Met QC Criteria

February 2, 2025

First Posted (Actual)

February 6, 2025

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 31, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • ANES-2020-29144

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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