3D Assessment of Right Ventricular Function in LVAD Patients
This observational study aims to assess the function of the right ventricle in patients with Left Ventricular Assist Devices (LVADs) by evaluating various factors, including ejection fractions, ventricular volumes, and ventricular strains.
Data Collection
Collected from today forward - ProspectiveCardiovascular Diseases
+ Heart Diseases
+ Heart Failure
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: March 22, 2022
Actual date on which the first participant was enrolled.This study focuses on patients who need a left ventricular assist device (LVAD), a mechanical pump that helps the heart when the left ventricle is too weak to pump blood effectively. The right ventricle, which pumps blood to the lungs, can sometimes struggle after an LVAD is implanted. This can lead to complications. The study aims to predict which patients might have this issue, using advanced 3D imaging of the right ventricle during the LVAD surgery. This is important because it could help doctors prepare for potential complications and improve patient care. During the study, 3D images of the right ventricle are taken using a special type of ultrasound called transesophageal echocardiography (TEE). These images are then analyzed to understand how well the right ventricle is working. The study measures various aspects of heart function, such as the amount of blood pumped out by the right ventricle each time it contracts, and the amount of blood in the right ventricle before and after it contracts. These measurements help assess the risk of right ventricle failure within 14 days of the LVAD implantation.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 16 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Mazankowski Alberta Heart Institute
Edmonton, CanadaOpen Mazankowski Alberta Heart Institute in Google Maps