Clinical trial NCT05376254: 3D Assessment of RV Function in Patients Undergoing LVAD Implantation
Official title: Three-Dimensional Assessment of Right Ventricular Function in Patients Undergoing Left Ventricular Assist Device Implantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Keywords: Right Ventricular Function
Left Ventricular Assist Device
3D transesophageal echocardiography
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients coming for left ventricular assist device implantation.

Brief summary: 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.

Detailed description: There are two chambers in the heart known as ventricles which are responsible for pumping blood to both the lungs and the rest of the body. The right ventricle pumps blood to the lungs for oxygenation. The left ventricle then delivers this oxygenated blood to the organs in the body. When the left ventricle is damaged enough that it is not able to effectively pump blood then it may be necessary to assist it with a mechanical pump. This pump is called left ventricular assist device (LVAD).

Left ventricular assist devices (LVADs) improve quality of life and survival in patients with end stage heart failure. However, right ventricular (RV) failure is common in 20-50% of LVAD recipients and is associated with perioperative complications.

Traditional two-dimensional ultrasound views of the right ventricle may not accurately depict how well or poorly the right ventricle is working. Three-dimensional (3D) images can overcome the limitations of two-dimensional images and are becoming more commonplace. This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during the LVAD implantation to help predict which patients are at higher risk of right ventricular failure within 14 days of the procedure.

Eligibility 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

Primary outcomes:
measure: Left ventricular strain
timeFrame: 24 hours
measure: Right ventricular fractional area of change
timeFrame: 24 hours
measure: Right ventricular free wall strain
timeFrame: 24 hours
measure: Right ventricular end diastolic volume
timeFrame: 24 hours
measure: Light ventricular end diastolic volume
timeFrame: 24 hours
measure: Right ventricular end systolic volume
timeFrame: 24 hours
measure: Left ventricular end systolic volume
timeFrame: 24 hours
measure: Right ventricular ejection fraction
timeFrame: 24 hours
measure: Left ventricular ejection fraction
timeFrame: 24 hours
measure: Tricuspid annular plane systolic excursion
timeFrame: 24 hours
Secondary outcomes:
measure: Age
timeFrame: 1 day
measure: Gender
timeFrame: 1 day
measure: Body Surface Area
timeFrame: 1 day
measure: Central venous pressure
timeFrame: 14 days
measure: Pulmonary artery pulsatility index
timeFrame: 14 days
measure: Need for right ventricular mechanical support
timeFrame: 14 days
measure: Need for pulmonary vasodilators
timeFrame: 14 days
measure: Need for vasopressors
timeFrame: 14 days
measure: Aspartate aminotransferase
timeFrame: 14 days
measure: Bilirubin
timeFrame: 14 days
measure: Creatinine
timeFrame: 14 days
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Mazankowski Alberta Heart Institute
state: Alberta
Study officials:
affiliation: University of Alberta
name: Surita Sidhu, MD
role: PRINCIPAL_INVESTIGATOR
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