3D Imaging Study of Right Heart Function During Mechanical Pump Placement for Heart Failure
Led by University of Alberta · Updated on 2026-05-29
200
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
The trial investigates the use of 3D transesophageal echocardiography TEE to analyze the right ventricles 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
Research Team
S
Surita Sidhu, MD
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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
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
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
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
Accuracy of right ventricular volumes and function determined by three-dimensional echocardiography in comparison with magnetic resonance imaging: a meta-analysis study.
Yuichi J Shimada, Maiko Shiota, Robert J Siegel...
Quantitative Assessment of Right Ventricular Volumes and Ejection Fraction in Patients with Left Ventricular Systolic Dysfunction by Real Time Three-Dimensional Echocardiography versus Cardiac Magnetic Resonance Imaging.
Echocardiographic assessment of right ventricular volumes: a comparison of different techniques in children after surgical repair of tetralogy of Fallot.
Andrea Dragulescu, Lars Grosse-Wortmann, Cheryl Fackoury...
Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography.
Lawrence G Rudski, Wyman W Lai, Jonathan Afilalo...
Anatomically oriented right ventricular volume measurements with dynamic three-dimensional echocardiography validated by 3-Tesla magnetic resonance imaging.