Echocardiographic Assessment of the Effect of Impella on Biventricular Function

The objective of this prospective observational study is to evaluate the effects of Impella 5.5 on biventricular function in adult patients with end-stage heart failure requiring temporary mechanical circulatory support. The study will assess changes in left and right ventricular global longitudinal strain and myocardial work, as well as additional echocardiographic and hemodynamic parameters. Measurements will be obtained at baseline prior to Impella implantation, immediately after device initiation, and during postoperative follow-up between 7 and 14 days. This study involves collection of echocardiographic imaging and clinical data, including additional imaging performed for research purposes.

Study Overview

• Status: Not yet recruiting
• Conditions: End-stage Heart Failure
• Intervention / Treatment: Diagnostic test: Echocardiographic Assessment

Detailed Description

This is a single-center, single-arm, prospective observational study designed to evaluate the effects of Impella 5.5 on left ventricular unloading and biventricular function in patients with end-stage heart failure requiring temporary mechanical circulatory support.

Echocardiographic assessments will be performed at three time points: prior to Impella implantation (baseline), immediately after device initiation intraoperatively, and during postoperative follow-up between Day 7 and Day 14. Measurements will include left and right ventricular global longitudinal strain, myocardial work, and standard echocardiographic parameters such as left ventricular ejection fraction, ventricular volumes, and right ventricular functional indices.

Hemodynamic parameters, including arterial blood pressure, central venous pressure, pulmonary artery pressure, cardiac output, and mixed venous oxygen saturation, will also be collected. The vasoactive inotropic score will be calculated to evaluate changes in pharmacologic support.

This study is observational in nature and does not alter clinical management. Additional echocardiographic imaging may be obtained for research purposes in conjunction with standard of care procedures.

• Study Type: Observational
• Enrollment (Estimated): 24

Contacts and Locations

• Study Contact: Name: YOSHIHISA MORITA; Phone Number: 585-275-2141; Email: yoshihisa_morita@urmc.rochester.edu
• Study Contact Backup: Name: Tammy Ortiz; Phone Number: 585-276-0005; Email: tammy_ortiz@urmc.rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) with cardiogenic shock and left ventricular ejection fraction <40% undergoing planned Impella 5.5 implantation at the University of Rochester Medical Center.

Description

Inclusion Criteria:

1. Adult patients over 18 years old
2. In cardiogenic shock status with LVEF<40%
3. Require Impella 5.5 implantation

Exclusion Criteria:

1. Patients' inability to provide consent for themselves (including that patients' lack of understanding the research)
2. Any patients who are deemed at higher-than-normal risk for complications secondary to echocardiography, such as dysphagia or esophageal pathology

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
End-stage heart failure patients receiving Impella 5.5; Adult patients with end-stage heart failure requiring Impella 5.5 for temporary mechanical circulatory support.	Diagnostic test: Echocardiographic Assessment; Echocardiographic imaging will be performed at baseline prior to Impella implantation, immediately after device initiation, and during postoperative follow-up between Day 7 and Day 14 to assess biventricular function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change from Baseline in Left Ventricular Global Longitudinal Strain (LV GLS)	Left ventricular global longitudinal strain will be measured using speckle-tracking echocardiography from transesophageal and transthoracic images. LV endocardial borders are manually traced, and strain is calculated as the average peak systolic longitudinal strain across left ventricular segments. Values are expressed as percentage. More negative values indicate better myocardial function.	Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14
Mean Change from Baseline in Left Ventricular Myocardial Work (MW	Left ventricular myocardial work will be calculated using pressure-strain loop analysis derived from echocardiographic strain data combined with non-invasive blood pressure measurements using EchoPac software. Higher values indicate improved myocardial performance.	Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14
Mean Change from Baseline in Right Ventricular Global Longitudinal Strain (RV GLS)	Right ventricular global longitudinal strain will be measured using speckle-tracking echocardiography from apical or transesophageal four-chamber views. RV free wall segments are analyzed and averaged to determine strain. Values are expressed as percentage. More negative values indicate better myocardial function.	Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change from Baseline in Left Ventricular Ejection Fraction (LVEF)	Left ventricular ejection fraction will be measured using three-dimensional echocardiographic imaging and automated quantification software. Higher values indicate better ventricular function.	Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14
Mean Change from Baseline in Left Ventricular End-Diastolic Volume (LVEDV)	Left ventricular end-diastolic volume will be measured using three-dimensional echocardiography and represents the volume of blood in the left ventricle at end-diastole.	Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14
Mean Change from Baseline in Left Ventricular End-Systolic Volume (LVESV)	Left ventricular end-systolic volume will be measured using three-dimensional echocardiography and represents the volume of blood remaining in the ventricle after contraction.	Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14
Mean Change from Baseline in Right Ventricular Ejection Fraction (RVEF)	Right ventricular ejection fraction will be assessed using three-dimensional echocardiographic imaging. Higher values indicate better ventricular function.	Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14
Mean Change from Baseline in Right Ventricular End-Diastolic Volume (RVEDV)	Right ventricular end-diastolic volume will be measured using three-dimensional echocardiography.	Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14
Mean Change from Baseline in Right Ventricular End-Systolic Volume (RVESV)	Right ventricular end-systolic volume will be measured using three-dimensional echocardiography.	Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14
Mean Change from Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE)	Tricuspid annular plane systolic excursion will be measured using M-mode echocardiography and reflects right ventricular longitudinal systolic function. Higher values indicate better right ventricular function.	Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14
Mean Change from Baseline in Right Ventricular Fractional Area Change (RV FAC)	Right ventricular fractional area change is calculated as the percentage change in right ventricular area between end-diastole and end-systole. Higher values indicate better right ventricular function.	Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Johnson & Johnson

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2027

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00010955

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No