Status:

COMPLETED

Paceport Swan-Ganz Data Collection Study

Lead Sponsor:

Montreal Heart Institute

Collaborating Sponsors:

Edwards Lifesciences

Conditions:

Right Ventricular Dysfunction

Right Heart Failure

Eligibility:

All Genders

18+ years

Brief Summary

RV dysfunction has been associated with increased mortality in the ICU and cardiac surgical patients. Thus, early identification of RV dysfunction at less severe stages will allow for earlier interven...

Detailed Description

The pulmonary artery catheter (PAC) consists of an intravenous device placed in the pulmonary artery to measure cardiac output, pulmonary artery pressures (Richard C, 2011) as well as cardiac filling ...

Eligibility Criteria

Inclusion

  • Be ≥ 18 years of age
  • Participate in the Informed Consent process and sign/date the approved informed consent forms
  • Projected to receive Swan-Ganz catheter as part of procedure/standard of care with intermittent cardiac output and mixed venous oxygen saturation (SvO2) measures

Exclusion

  • Refuse to sign consent
  • Have left bundle branch block
  • Have recurrent sepsis
  • Have hypercoagulopathy
  • Allergic to FORE-SIGHT Elite sensor adhesive
  • Latex allergy due to presence of latex in the Swan-Ganz catheter balloon.

Key Trial Info

Start Date :

August 9 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 1 2022

Estimated Enrollment :

136 Patients enrolled

Trial Details

Trial ID

NCT04782154

Start Date

August 9 2021

End Date

April 1 2022

Last Update

September 2 2022

Active Locations (1)

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Montreal Heart Institute

Montreal, Quebec, Canada, H1T 1C8