Recruiting

3D TEE

Sponsor:

University of Alberta

Code:

NCT05376254

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Heart Failure

Study ID

NCT05376254

Start date

Mar 22, 2022

Status verified date

May, 2026

Completion date

Jan 19, 2027

Anticipated

Primary completion date

Jan 19, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Accepted

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 Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Left ventricular strain [ Time Frame: 24 hours ]
  • Right ventricular fractional area of change [ Time Frame: 24 hours ]
  • Right ventricular free wall strain [ Time Frame: 24 hours ]
  • Right ventricular end diastolic volume [ Time Frame: 24 hours ]
  • Light ventricular end diastolic volume [ Time Frame: 24 hours ]
  • Right ventricular end systolic volume [ Time Frame: 24 hours ]
  • Left ventricular end systolic volume [ Time Frame: 24 hours ]
  • Right ventricular ejection fraction [ Time Frame: 24 hours ]
  • Left ventricular ejection fraction [ Time Frame: 24 hours ]
  • Tricuspid annular plane systolic excursion [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Surita Sidhu, MD

780-407-8861surita@ualberta.ca

Locations

Mazankowski Alberta Heart Institute

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Surita Sidhu, MD

780-407-8861surita@ualberta.ca

More Information

Sponsor

University of Alberta

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • Right Ventricular Function
  • Left Ventricular Assist Device
  • 3D transesophageal echocardiography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-05-29.