3D Assessment of RV Function in Patients Undergoing LVAD Implantation

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05376254
• Other study ID #: Pro00112239
• Status: Recruiting
• Start date: March 22, 2022
• Est. completion date: January 19, 2027

Study information

• Verified date: May 2023
• Source: University of Alberta
• Contact: Surita Sidhu, MD
• Phone: 780-407-8861
• Email: surita[@]ualberta.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 19, 2027
• Est. primary completion date: January 19, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Canada	Mazankowski Alberta Heart Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (23)

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular strain	Prognostic indicator of hypertensive heart failure	24 hours
Primary	Right ventricular fractional area of change	Percentage change in the RV chamber area between end-diastole to end-systole	24 hours
Primary	Right ventricular free wall strain	Prognostic indicator of pulmonary arterial hypertension	24 hours
Primary	Right ventricular end diastolic volume	Amount of blood in the heart's right ventricle just before the heart contracts	24 hours
Primary	Light ventricular end diastolic volume	Amount of blood in the heart's left ventricle just before the heart contracts	24 hours
Primary	Right ventricular end systolic volume	Amount of blood in the heart's right ventricle just after the heart contracts	24 hours
Primary	Left ventricular end systolic volume	Amount of blood in the heart's left ventricle just after the heart contracts	24 hours
Primary	Right ventricular ejection fraction	Amount of blood being pumped out of the right ventricle each time it contracts.	24 hours
Primary	Left ventricular ejection fraction	Amount of blood being pumped out of the left ventricle each time it contracts.	24 hours
Primary	Tricuspid annular plane systolic excursion	Parameter of global right ventricular function	24 hours
Secondary	Age	Demographic measure	1 day
Secondary	Gender	Demographic measure	1 day
Secondary	Body Surface Area	Demographic measure	1 day
Secondary	Central venous pressure	Pressure in the thoracic vena cava near the right atrium	14 days
Secondary	Pulmonary artery pulsatility index	Hemodynamic index	14 days
Secondary	Need for right ventricular mechanical support	Circulatory support	14 days
Secondary	Need for pulmonary vasodilators	Supportive medication	14 days
Secondary	Need for vasopressors	Supportive medications	14 days
Secondary	Aspartate aminotransferase	Lab test (> or qual to 80 IU/L)	14 days
Secondary	Bilirubin	Lab test (> 2.0 mg/dL)	14 days
Secondary	Creatinine	Lab test (> or equal to 2.3 mg/dL)	14 days