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Clinical Trials in Canada / NCT05376254
Recruiting Observational

3D Assessment of RV Function in Patients Undergoing LVAD Implantation

NCT05376254 · tracked via the Priya Life Science Canada tracker
Sponsor
University of Alberta
Phase
Observational
Started
2022-03-22
Last updated
2026-05-29

Condition(s) studied

Heart Failure

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

Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Patients will be eligible to be included in the study if they receive either a left-sided: 1. HeartMate III (Thoratec, Pleasanton, CA) 2. HeartWare HVAD (HeartWare, Oakville CA) 3. Levitronix CentriMag (Levitronix LLC, Waltham, MA) LVAD. Exclusion Criteria: * Patients will be excluded if:: 1. hemodynamic data needed to calculate PAPi or comprehensive echocardiographic images are missing 2. 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 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

Primary outcome measure(s)

  • Left ventricular strain — 24 hours
    Prognostic indicator of hypertensive heart failure
  • Right ventricular fractional area of change — 24 hours
    Percentage change in the RV chamber area between end-diastole to end-systole
  • Right ventricular free wall strain — 24 hours
    Prognostic indicator of pulmonary arterial hypertension
  • Right ventricular end diastolic volume — 24 hours
    Amount of blood in the heart's right ventricle just before the heart contracts
  • Light ventricular end diastolic volume — 24 hours
    Amount of blood in the heart's left ventricle just before the heart contracts
  • Right ventricular end systolic volume — 24 hours
    Amount of blood in the heart's right ventricle just after the heart contracts
  • Left ventricular end systolic volume — 24 hours
    Amount of blood in the heart's left ventricle just after the heart contracts
  • Right ventricular ejection fraction — 24 hours
    Amount of blood being pumped out of the right ventricle each time it contracts.
  • Left ventricular ejection fraction — 24 hours
    Amount of blood being pumped out of the left ventricle each time it contracts.
  • Tricuspid annular plane systolic excursion — 24 hours
    Parameter of global right ventricular function

Trial sites (1)

FacilityCityRegionStatus
Mazankowski Alberta Heart Institute Edmonton Alberta Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05376254 on ClinicalTrials.gov ↗ ← All trials in Canada