3D Assessment of RV Function in Patients Undergoing LVAD Implantation

NCT05376254 | Recruiting

• 1 other identifier: Pro00112239
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (10)

• Left ventricular strain

  Prognostic indicator of hypertensive heart failure

  24 hours

• Right ventricular fractional area of change

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

  24 hours

• Right ventricular free wall strain

  Prognostic indicator of pulmonary arterial hypertension

  24 hours

• Right ventricular end diastolic volume

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

  24 hours

• Light ventricular end diastolic volume

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

  24 hours

• Right ventricular end systolic volume

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

  24 hours

• Left ventricular end systolic volume

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

  24 hours

• Right ventricular ejection fraction

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

  24 hours

• Left ventricular ejection fraction

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

  24 hours

• Tricuspid annular plane systolic excursion

  Parameter of global right ventricular function

  24 hours

Secondary Outcomes (11)

• Age

  1 day

• Gender

  1 day

• Body Surface Area

  1 day

• Central venous pressure

  14 days

• Pulmonary artery pulsatility index

  14 days

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients coming for left ventricular assist device implantation.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Mazankowski Alberta Heart Institute

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Related Publications (23)

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  PMID: 29903518 BACKGROUND

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  PMID: 18378625 BACKGROUND

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MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Surita Sidhu, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Surita Sidhu, MD

CONTACT

780-407-8861; surita@ualberta.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: May 17, 2022
• Study Start: March 22, 2022
• Primary Completion (Estimated): January 19, 2027
• Study Completion (Estimated): January 19, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

CA (1)