Status:

RECRUITING

3D Assessment of RV Function in Patients Undergoing LVAD Implantation

Lead Sponsor:

University of Alberta

Conditions:

Heart Failure

Eligibility:

All Genders

16+ years

Brief Summary

This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during left ventricular assist device (LVAD) implantation.

Detailed Description

There are two chambers in the heart known as ventricles which are responsible for pumping blood to both the lungs and the rest of the body. The right ventricle pumps blood to the lungs for oxygenation...

Eligibility Criteria

Inclusion

  • Patients will be eligible to be included in the study if they receive either a left-sided:
  • HeartMate III (Thoratec, Pleasanton, CA)
  • HeartWare HVAD (HeartWare, Oakville CA)
  • Levitronix CentriMag (Levitronix LLC, Waltham, MA) LVAD.

Exclusion

  • Patients will be excluded if::
  • hemodynamic data needed to calculate PAPi or comprehensive echocardiographic images are missing
  • additional procedures affecting cardiac geometry and/or hemodynamic measurements, such as tricuspid, mitral, and/or aortic valve repair/replacement, were performed at the time of LVAD implantation
  • sternal closure at the end of the procedure is not possible
  • RV mechanical support was introduced concurrently with LVAD implantation
  • inadequate image quality required to obtain a 3D protocol
  • known contraindication to TEE
  • unexpected inability to advance probe into the mid-esophagus

Key Trial Info

Start Date :

March 22 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 19 2027

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT05376254

Start Date

March 22 2022

End Date

January 19 2027

Last Update

May 25 2025

Active Locations (1)

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Mazankowski Alberta Heart Institute

Edmonton, Alberta, Canada, T6G 2B7