Recruiting

Impella 5.5

Sponsor:

University of Rochester

Code:

NCT07534462

Conditions

End-stage Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Echocardiographic Assessment

Study Details

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

Conditions

End-stage Heart Failure

Study ID

NCT07534462

Start date

Jul 11, 2026

Status verified date

Sep, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adult patients over 18 years old
2. 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 Design

Enrollment

24 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Echocardiographic Assessment

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 outcome measure

  • 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 ]
  • Mean Change from Baseline in Left Ventricular Myocardial Work (MW [ Time Frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day14 ]
  • 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 ]

Central Contacts and Locations

Central contacts

YOSHIHISA MORITA

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

Tammy Ortiz

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

Locations

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

More Information

Sponsor

University of Rochester

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-09-09.