3D Assessment of RV Function in Patients Undergoing LVAD Implantation

Last updated: May 17, 2024
Sponsor: University of Alberta
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Hyponatremia

Chest Pain

Treatment

N/A

Clinical Study ID

NCT05376254
Pro00112239
  • Ages > 16
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients will be eligible to be included in the study if they receive either aleft-sided:

  1. HeartMate III (Thoratec, Pleasanton, CA)

  2. HeartWare HVAD (HeartWare, Oakville CA)

  3. Levitronix CentriMag (Levitronix LLC, Waltham, MA) LVAD.

Exclusion

Exclusion Criteria:

  • Patients will be excluded if::

  1. hemodynamic data needed to calculate PAPi or comprehensive echocardiographicimages are missing

  2. additional procedures affecting cardiac geometry and/or hemodynamicmeasurements, such as tricuspid, mitral, and/or aortic valverepair/replacement, were performed at the time of LVAD implantation

  3. sternal closure at the end of the procedure is not possible

  4. RV mechanical support was introduced concurrently with LVAD implantation

  5. inadequate image quality required to obtain a 3D protocol

  6. known contraindication to TEE

  7. unexpected inability to advance probe into the mid-esophagus

Study Design

Total Participants: 200
Study Start date:
March 22, 2022
Estimated Completion Date:
January 19, 2027

Study 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. The left ventricle then delivers this oxygenated blood to the organs in the body. When the left ventricle is damaged enough that it is not able to effectively pump blood then it may be necessary to assist it with a mechanical pump. This pump is called left ventricular assist device (LVAD).

Left ventricular assist devices (LVADs) improve quality of life and survival in patients with end stage heart failure. However, right ventricular (RV) failure is common in 20-50% of LVAD recipients and is associated with perioperative complications.

Traditional two-dimensional ultrasound views of the right ventricle may not accurately depict how well or poorly the right ventricle is working. Three-dimensional (3D) images can overcome the limitations of two-dimensional images and are becoming more commonplace. This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during the LVAD implantation to help predict which patients are at higher risk of right ventricular failure within 14 days of the procedure.

Connect with a study center

  • Mazankowski Alberta Heart Institute

    Edmonton, Alberta T6G 2B7
    Canada

    Active - Recruiting

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