3D Assessment of RV Function in Patients Undergoing LVAD Implantation
Recruiting · NCT05376254 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Alberta
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
16 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Patients will be eligible to be included in the study if they receive either a left-sided:
- HeartMate III (Thoratec, Pleasanton, CA)
- HeartWare HVAD (HeartWare, Oakville CA)
- Levitronix CentriMag (Levitronix LLC, Waltham, MA) LVAD.
Exclusion criteria
- Patients will be excluded if::
- hemodynamic data needed to calculate PAPi or comprehensive echocardiographic images are missing
- 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
- sternal closure at the end of the procedure is not possible
- RV mechanical support was introduced concurrently with LVAD implantation
- inadequate image quality required to obtain a 3D protocol
- known contraindication to TEE
- unexpected inability to advance probe into the mid-esophagus
Where it is running
1 location listed.
- Mazankowski Alberta Heart Institute - Edmonton, Alberta, Canada