3D Assessment of RV Function in Patients Undergoing LVAD Implantation

NCT ID: NCT05376254

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-22
• Study Completion Date: 2027-01-19

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.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Surita Sidhu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Mazankowski Alberta Heart Institute

Edmonton, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Surita Sidhu, MD

Role: CONTACT

surita@ualberta.ca

780-407-8861

Facility Contacts

Surita Sidhu, MD

Role: primary

surita@ualberta.ca

780-407-8861

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Other Identifiers

Pro00112239

Identifier Type: -

Identifier Source: org_study_id