Echocardiographic Assessment of the Effect of Impella on Biventricular Function

NCT07534462 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY00010955
• Study Type: observational
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

End-stage Heart Failure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

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

  Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14

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

  Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14

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

  Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14

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

  Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14

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

  Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14

Study Arms (1)

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

Interventions

Echocardiographic Assessment DIAGNOSTIC_TEST

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.

End-stage heart failure patients receiving Impella 5.5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult patients over 18 years old
• In cardiogenic shock status with LVEF\<40%
• Require Impella 5.5 implantation

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Johnson & Johnson: collaborator

Central Study Contacts

YOSHIHISA MORITA

CONTACT

585-275-2141; yoshihisa_morita@urmc.rochester.edu

Tammy Ortiz

CONTACT

585-276-0005; tammy_ortiz@urmc.rochester.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Department of Anesthesiology and Perioperative Medicine (SMD)

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04