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NCT Number: NCT05376254

3D Assessment of RV Function in Patients Undergoing LVAD 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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mazankowski Alberta Heart Institute

Edmonton, Alberta, T6G 2B7, Canada

Location status: Recruiting

Location contact

Surita Sidhu, MD

CONTACT

[email protected]

780-407-8861

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Left ventricular strain

    Time frame: 24 hours

    Prognostic indicator of hypertensive heart failure

  2. Right ventricular fractional area of change

    Time frame: 24 hours

    Percentage change in the RV chamber area between end-diastole to end-systole

  3. Right ventricular free wall strain

    Time frame: 24 hours

    Prognostic indicator of pulmonary arterial hypertension

  4. Right ventricular end diastolic volume

    Time frame: 24 hours

    Amount of blood in the heart's right ventricle just before the heart contracts

  5. Light ventricular end diastolic volume

    Time frame: 24 hours

    Amount of blood in the heart's left ventricle just before the heart contracts

  6. Right ventricular end systolic volume

    Time frame: 24 hours

    Amount of blood in the heart's right ventricle just after the heart contracts

  7. Left ventricular end systolic volume

    Time frame: 24 hours

    Amount of blood in the heart's left ventricle just after the heart contracts

  8. Right ventricular ejection fraction

    Time frame: 24 hours

    Amount of blood being pumped out of the right ventricle each time it contracts.

  9. Left ventricular ejection fraction

    Time frame: 24 hours

    Amount of blood being pumped out of the left ventricle each time it contracts.

  10. Tricuspid annular plane systolic excursion

    Time frame: 24 hours

    Parameter of global right ventricular function

Secondary outcomes

  1. Age

    Time frame: 1 day

    Demographic measure

  2. Gender

    Time frame: 1 day

    Demographic measure

  3. Body Surface Area

    Time frame: 1 day

    Demographic measure

  4. Central venous pressure

    Time frame: 14 days

    Pressure in the thoracic vena cava near the right atrium

  5. Pulmonary artery pulsatility index

    Time frame: 14 days

    Hemodynamic index

  6. Need for right ventricular mechanical support

    Time frame: 14 days

    Circulatory support

  7. Need for pulmonary vasodilators

    Time frame: 14 days

    Supportive medication

  8. Need for vasopressors

    Time frame: 14 days

    Supportive medications

  9. Aspartate aminotransferase

    Time frame: 14 days

    Lab test (> or qual to 80 IU/L)

  10. Bilirubin

    Time frame: 14 days

    Lab test (> 2.0 mg/dL)

  11. Creatinine

    Time frame: 14 days

    Lab test (> or equal to 2.3 mg/dL)

Study contacts

Contact information is provided by the study sponsor or research team.

Surita Sidhu, MD

CONTACT

[email protected]

780-407-8861

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 17, 2022
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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