Echocardiographic Assessment of the Effect of Impella on Biventricular Function
Recruiting · NCT07534462 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Adult patients over 18 years old
- Require Impella 5.5 implantation
Exclusion criteria
- 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
Where it is running
1 location listed across 1 US state.
- University of Rochester Medical Center - Rochester, New York, United States