Impact of Impella 5.5 on heart function in adults with end-stage heart failure
Official title: Echocardiographic Assessment of the Effect of Impella on Biventricular Function
Run by University of Rochester · NCT07534462 · Data updated 2026-11-12
This study tests whether the Impella 5.5 helps the heart’s two sides work better in adults with severe heart failure who need temporary support.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Status | Recruiting |
| Started | July 11, 2026 |
| Main results expected | July 1, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT07534462 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with end-stage heart failure who require Impella 5.5 implantation.
✕Probably not a fit
Patients who do not receive meaningful changes in ventricular function or who do not complete follow-up may not benefit from the study findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-center observational study evaluating how Impella 5.5 affects both left and right ventricular function in adults with end-stage heart failure. Researchers will measure heart strains, myocardial work, standard echocardiographic metrics, and hemodynamics at baseline, immediately after device start, and up to 14 days after implantation. Data collection includes echocardiographic imaging and related clinical information, with some imaging obtained for research alongside routine care. The study does not modify patient management, and additional imaging may be performed for research purposes.
Why it matters
Potential benefit: If successful, the findings could improve understanding of how Impella 5.5 supports both heart ventricles in this population.
How similar studies have gone: Previous research in this area has shown that ventricular unloading with mechanical support can influence cardiac function, but this specific assessment is relatively novel for Impella 5.5.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Rochester Medical Center
Rochester, New York, United States Recruiting
Study contacts
- Study coordinator: Yoshihisa Morita
- Email: yoshihisa_morita@urmc.rochester.edu
- Phone: 585-275-2141
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.