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NCT07534462
Echocardiographic Assessment of the Effect of Impella on Biventricular Function
Conditions: End-stage Heart Failure
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 24
Sponsor: University of Rochester
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07534462). StuddyBuddy aggregates publicly available trial information.