Impella 5.5 Echocardiographic Study on Heart Failure
Summary
The NIH has registered a prospective observational clinical study (NCT07534462) on ClinicalTrials.gov evaluating the effects of the Impella 5.5 mechanical circulatory support device on biventricular function in adult patients with end-stage heart failure. The study will assess echocardiographic parameters including left and right ventricular global longitudinal strain and myocardial work at baseline, immediately after device initiation, and during 7-14 day follow-up. This observational study involves collection of echocardiographic imaging and clinical data from patients requiring temporary mechanical circulatory support.
What changed
The NIH registered a new prospective observational clinical trial (NCT07534462) titled 'Echocardiographic Assessment of the Effect of Impella on Biventricular Function' on ClinicalTrials.gov. The study will enroll adult patients with end-stage heart failure requiring temporary mechanical circulatory support and evaluate the Impella 5.5 device's effects on left and right ventricular function using echocardiographic parameters including global longitudinal strain and myocardial work.
Affected parties include clinical research institutions conducting cardiovascular device studies, hospitals utilizing Impella mechanical circulatory support systems, and medical device manufacturers conducting post-market or investigator-initiated research. The study registration establishes transparency requirements for clinical research involving cardiac support devices and provides public access to study design and objectives.
Archived snapshot
Apr 16, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Echocardiographic Assessment of the Effect of Impella on Biventricular Function
Observational NCT07534462 Kind: OBSERVATIONAL Apr 16, 2026
Abstract
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
Interventions: Echocardiographic Assessment
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