3D Assessment of RV Function in Patients Undergoing LVAD Implantation

May 28, 2026 updated by: University of Alberta

Three-Dimensional Assessment of Right Ventricular Function in Patients Undergoing Left Ventricular Assist Device Implantation

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • Mazankowski Alberta Heart Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

All patients coming for left ventricular assist device implantation.

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular strain
Time Frame: 24 hours
Prognostic indicator of hypertensive heart failure
24 hours
Right ventricular fractional area of change
Time Frame: 24 hours
Percentage change in the RV chamber area between end-diastole to end-systole
24 hours
Right ventricular free wall strain
Time Frame: 24 hours
Prognostic indicator of pulmonary arterial hypertension
24 hours
Right ventricular end diastolic volume
Time Frame: 24 hours
Amount of blood in the heart's right ventricle just before the heart contracts
24 hours
Light ventricular end diastolic volume
Time Frame: 24 hours
Amount of blood in the heart's left ventricle just before the heart contracts
24 hours
Right ventricular end systolic volume
Time Frame: 24 hours
Amount of blood in the heart's right ventricle just after the heart contracts
24 hours
Left ventricular end systolic volume
Time Frame: 24 hours
Amount of blood in the heart's left ventricle just after the heart contracts
24 hours
Right ventricular ejection fraction
Time Frame: 24 hours
Amount of blood being pumped out of the right ventricle each time it contracts.
24 hours
Left ventricular ejection fraction
Time Frame: 24 hours
Amount of blood being pumped out of the left ventricle each time it contracts.
24 hours
Tricuspid annular plane systolic excursion
Time Frame: 24 hours
Parameter of global right ventricular function
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age
Time Frame: 1 day
Demographic measure
1 day
Gender
Time Frame: 1 day
Demographic measure
1 day
Body Surface Area
Time Frame: 1 day
Demographic measure
1 day
Central venous pressure
Time Frame: 14 days
Pressure in the thoracic vena cava near the right atrium
14 days
Pulmonary artery pulsatility index
Time Frame: 14 days
Hemodynamic index
14 days
Need for right ventricular mechanical support
Time Frame: 14 days
Circulatory support
14 days
Need for pulmonary vasodilators
Time Frame: 14 days
Supportive medication
14 days
Need for vasopressors
Time Frame: 14 days
Supportive medications
14 days
Aspartate aminotransferase
Time Frame: 14 days
Lab test (> or qual to 80 IU/L)
14 days
Bilirubin
Time Frame: 14 days
Lab test (> 2.0 mg/dL)
14 days
Creatinine
Time Frame: 14 days
Lab test (> or equal to 2.3 mg/dL)
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Surita Sidhu, MD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2022

Primary Completion (Estimated)

January 19, 2027

Study Completion (Estimated)

January 19, 2027

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

May 13, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00112239

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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