Echocardiographic Assessment of the Effect of Impella on Biventricular Function

Conditions

• End-stage Heart Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed

Apr 16, 2026

Start date

Jul 11, 2026

Status verified

Sep 2026

Primary completion

Jul 1, 2027

Completion

Jul 1, 2027

Study Design

Enrollment

24 participants (estimated)

Arms

• Arm: End-stage heart failure patients receiving Impella 5.5
  Adult patients with end-stage heart failure requiring Impella 5.5 for temporary mechanical circulatory support.

Primary Outcome Measure

Mean Change from Baseline in Left Ventricular Global Longitudinal Strain (LV GLS) [ Time Frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14 ]

Central Contacts

• YOSHIHISA MORITA
  585-275-2141
  [email protected]
• Tammy Ortiz
  585-276-0005
  [email protected]

Locations (1)

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