Not Yet RecruitingNot Applicable

Echocardiographic Assessment of the Effect of Impella on Biventricular Function

24 participantsStarted 2026-04-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adult patients over 18 years old
. In cardiogenic shock status with LVEF\<40%
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Change from Baseline in Left Ventricular Global Longitudinal Strain (LV GLS)

Timeframe: Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14

Mean Change from Baseline in Left Ventricular Myocardial Work (MW

Timeframe: Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14

Mean Change from Baseline in Right Ventricular Global Longitudinal Strain (RV GLS)

Timeframe: Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14

Trial details

NCT IDNCT07534462

SponsorUniversity of Rochester

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-04-15

Contact for this trial

YOSHIHISA MORITA

585-275-2141 yoshihisa_morita@urmc.rochester.edu

View on ClinicalTrials.gov More End-stage Heart Failure trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Adult patients over 18 years old
. In cardiogenic shock status with LVEF\<40%
. 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

What they're measuring

Mean Change from Baseline in Left Ventricular Global Longitudinal Strain (LV GLS)

Timeframe: Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14

Mean Change from Baseline in Left Ventricular Myocardial Work (MW

Timeframe: Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14

Mean Change from Baseline in Right Ventricular Global Longitudinal Strain (RV GLS)

Timeframe: Baseline, immediately post-Impella initiation, and postoperative Day 7 to Day 14