Analyzing Right Ventricular Function During LVAD Implantation
Official title: Three-Dimensional Assessment of Right Ventricular Function in Patients Undergoing Left Ventricular Assist Device Implantation
Run by University of Alberta · NCT05376254 · Data updated 2026-11-12
This study is testing if 3D imaging can help doctors see how well the right side of the heart is working during LVAD surgery to better predict which patients might have problems afterward.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Status | Recruiting |
| Started | March 22, 2022 |
| Main results expected | January 19, 2027 |
| Study ends | January 19, 2027 |
| Registry record updated | May 29, 2026 |
| Trial ID | NCT05376254 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients receiving specific types of left-sided LVADs, such as HeartMate III, HeartWare HVAD, or Levitronix CentriMag.
✕Probably not a fit
Patients who have concurrent procedures affecting cardiac geometry or those with contraindications to transesophageal echocardiography may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the right ventricle's function in patients undergoing left ventricular assist device (LVAD) implantation using 3D transesophageal echocardiography (TEE). The right ventricle is crucial for pumping blood to the lungs, and its failure can complicate LVAD procedures. By capturing 3D images during the implantation, researchers hope to better predict which patients are at higher risk of right ventricular failure within 14 days post-procedure. This approach seeks to improve patient outcomes by identifying those who may need closer monitoring or additional interventions.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for patients undergoing LVAD implantation.
How similar studies have gone: While the use of 3D echocardiography is becoming more common, this specific approach to assessing right ventricular function during LVAD implantation is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada Recruiting
Study contacts
- Principal investigator: Surita Sidhu, MD — University of Alberta
- Study coordinator: Surita Sidhu, MD
- Email: surita@ualberta.ca
- Phone: 780-407-8861
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.