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NCT Number: NCT07534462

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 up to Day 14. This study involves collection of echocardiographic imaging and clinical data, including additional imaging performed for research purposes.

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Key information

Conditions

End-stage Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location status: Recruiting

About this study

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 up to 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients over 18 years old
  • Require Impella 5.5 implantation

Exclusion criteria

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

Treatment and study plan

Echocardiographic assessment

Diagnostic Test

Echocardiographic imaging will be performed at baseline prior to Impella implantation, immediately after device initiation, and during postoperative follow-up up to Day 14 to assess biventricular function.

Primary outcomes

  1. Mean Change from Baseline in Left Ventricular Global Longitudinal Strain (LV GLS)

    Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14

    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.

  2. Mean Change from Baseline in Left Ventricular Myocardial Work (MW

    Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day14

    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.

  3. Mean Change from Baseline in Right Ventricular Global Longitudinal Strain (RV GLS)

    Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14

    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.

Secondary outcomes

  1. Mean Change from Baseline in Left Ventricular Ejection Fraction (LVEF)

    Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14

    Left ventricular ejection fraction will be measured using three-dimensional echocardiographic imaging and automated quantification software. Higher values indicate better ventricular function.

  2. Mean Change from Baseline in Left Ventricular End-Diastolic Volume (LVEDV)

    Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14

    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.

  3. Mean Change from Baseline in Left Ventricular End-Systolic Volume (LVESV)

    Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14

    Left ventricular end-systolic volume will be measured using three-dimensional echocardiography and represents the volume of blood remaining in the ventricle after contraction.

  4. Mean Change from Baseline in Right Ventricular Ejection Fraction (RVEF)

    Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14

    Right ventricular ejection fraction will be assessed using three-dimensional echocardiographic imaging. Higher values indicate better ventricular function.

  5. Mean Change from Baseline in Right Ventricular End-Diastolic Volume (RVEDV)

    Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14

    Right ventricular end-diastolic volume will be measured using three-dimensional echocardiography.

  6. Mean Change from Baseline in Right Ventricular End-Systolic Volume (RVESV)

    Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14

    Right ventricular end-systolic volume will be measured using three-dimensional echocardiography.

  7. Mean Change from Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE)

    Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14

    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.

  8. Mean Change from Baseline in Right Ventricular Fractional Area Change (RV FAC)

    Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14

    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.

Study contacts

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

Tammy Ortiz

CONTACT

[email protected]

585-276-0005

YOSHIHISA MORITA

CONTACT

[email protected]

585-275-2141

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Johnson & Johnson

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2026
Registry last updated
Sep 9, 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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