Clinical Trial

Echocardiographic Assessment of the Effect of Impella on Biventricular Function

Not Yet Recruiting
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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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2027-04-15 -> 2027-07-01 2026-07-02
minor Completion pushed: 2027-04-15 -> 2027-07-01 2026-07-02
Trial Details
NCT Number NCT07534462
Lead Sponsor University of Rochester
Collaborators: Johnson & Johnson
Conditions End-stage Heart Failure
Enrollment 24 participants
Start Date 2026-07-01
Primary Completion 2027-07-01 (estimated)
Study Completion 2027-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-01