NCT07534462

Echocardiographic Assessment of the Effect of Impella on Biventricular Function

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 24 (estimated)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 between 7 and 14 days. This study involves collection of echocardiographic imaging and clinical data, including additional imaging performed for research purposes.

Detailed description

This is a single-center, single-arm, prospective observational study designed to evaluate the effects of Impella 5.5 on left ventricular unloading and biventricular function in patients with end-stage heart failure requiring temporary mechanical circulatory support. Echocardiographic assessments will be performed at three time points: prior to Impella implantation (baseline), immediately after device initiation intraoperatively, and during postoperative follow-up between Day 7 and Day 14. Measurements will include left and right ventricular global longitudinal strain, myocardial work, and standard echocardiographic parameters such as left ventricular ejection fraction, ventricular volumes, and right ventricular functional indices. Hemodynamic parameters, including arterial blood pressure, central venous pressure, pulmonary artery pressure, cardiac output, and mixed venous oxygen saturation, will also be collected. The vasoactive inotropic score will be calculated to evaluate changes in pharmacologic support. This study is observational in nature and does not alter clinical management. Additional echocardiographic imaging may be obtained for research purposes in conjunction with standard of care procedures.

Conditions

• End-stage Heart Failure

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Echocardiographic Assessment	Echocardiographic imaging will be performed at baseline prior to Impella implantation, immediately after device initiation, and during postoperative follow-up between Day 7 and Day 14 to assess biventricular function.

Timeline

• Start date: 2026-04-15
• Primary completion: 2027-04-15
• Completion: 2027-04-15
• First posted: 2026-04-16
• Last updated: 2026-04-16

Regulatory

• FDA-regulated device study