Actively Recruiting

Age: 16Years +
All Genders
Healthy Volunteers
ID05376254

Three-Dimensional Assessment of Right Ventricular Function in Patients Undergoing Left Ventricular Assist Device Implantation

Led by University of Alberta · Updated on 2026-05-29

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

The trial investigates the use of 3D transesophageal echocardiography (TEE) to analyze the right ventricle's function in patients undergoing left ventricular assist device (LVAD) implantation. LVADs help support the left ventricle in patients with severe heart failure. Because right ventricular failure after LVAD implantation is common and linked to complications, this study aims to better predict which patients are at higher risk by using advanced 3D imaging methods. Participants receive one of several types of left-sided LVADs, including HeartMate III, HeartWare HVAD, or Levitronix CentriMag devices. During the LVAD implantation procedure, 3D TEE images of the right ventricle are taken and analyzed. The study focuses on gathering detailed heart function data and does not involve additional treatments or interventions beyond standard device implantation. During the study, researchers collect various heart function measurements within 24 hours after implantation, such as ventricular strain, volumes, ejection fractions, and tricuspid annular plane systolic excursion. Secondary outcomes include monitoring clinical data and lab tests over 14 days post-implantation. Participants are observed for right ventricular function and related support needs. The study started in March 2022 and will continue through January 2027, involving no experimental treatments beyond imaging and data collection.

CONDITIONS

Brief Title

3D Assessment of RV Function in Patients Undergoing LVAD Implantation

Who Can Participate

Age: 16Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients receiving a left-sided HeartMate III LVAD
  • Patients receiving a left-sided HeartWare HVAD LVAD
  • Patients receiving a left-sided Levitronix CentriMag LVAD
  • Patients aged 16 years or older
Not Eligible

You will not qualify if you...

  • Missing hemodynamic data needed to calculate pulmonary artery pulsatility index or comprehensive echocardiographic images
  • Additional heart valve repair or replacement during LVAD implantation (tricuspid, mitral, or aortic)
  • Inability to close the sternum at the end of the procedure
  • Right ventricular mechanical support introduced at the same time as LVAD implantation
  • Poor image quality preventing 3D imaging protocol
  • Known contraindication to transesophageal echocardiography (TEE)
  • Inability to advance the probe into the mid-esophagus for imaging

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Day of LVAD implantation

Participants undergo three-dimensional transesophageal echocardiography (TEE) imaging during left ventricular assist device implantation to assess right ventricular function.

1 imaging session during surgery

Post-operative Follow-up

Duration - 14 days

Participants are monitored for right ventricular function and other clinical parameters following LVAD implantation.

Assessments over 14 days post-surgery

Trial Site Locations

Total: 1 location

1

Mazankowski Alberta Heart Institute

Edmonton, Alberta, Canada, T6G 2B7

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Research Team

S

Surita Sidhu, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Right Ventricular Dysfunction and Short-Term Outcomes Following Left-Sided Valvular Surgery: An Echocardiographic Study.

Arooge Towheed, Ebrahim Sabbagh, Rajesh Gupta...

https://pubmed.ncbi.nlm.nih.gov/33559474

Evaluation and Management of Right-Sided Heart Failure: A Scientific Statement From the American Heart Association.

Marvin A Konstam, Michael S Kiernan, Daniel Bernstein...

https://pubmed.ncbi.nlm.nih.gov/29650544

The International Society of Heart and Lung Transplantation Guidelines for the care of heart transplant recipients.

Maria Rosa Costanzo, Anne Dipchand, Randall Starling...

https://pubmed.ncbi.nlm.nih.gov/20643330

3D echocardiography derived right ventricular function is associated with right ventricular failure and mid-term survival after left ventricular assist device implantation.

Harry Magunia, Clemens Dietrich, Harald F Langer...

https://pubmed.ncbi.nlm.nih.gov/29903518

Right ventricular function in cardiovascular disease, part II: pathophysiology, clinical importance, and management of right ventricular failure.

François Haddad, Ramona Doyle, Daniel J Murphy...

https://pubmed.ncbi.nlm.nih.gov/18378625