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Echocardiographic Assessment of the Effect of Impella on Biventricular Function

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how the Impella 5.5, a device that helps the heart pump blood for a short time, affects both sides of the heart. It is for adults with very severe heart failure who need this device. Researchers will use heart ultrasound scans and health data before and after the device is placed, with follow-up for up to 14 days.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are older than 18.
  • You need an Impella 5.5 device placed to help your heart pump blood.

Who can't join

  • You cannot give consent for yourself, including if you cannot understand the study.
  • You have a higher-than-normal risk of problems from heart ultrasound scans, such as trouble swallowing or a problem with the tube that carries food from your mouth to your stomach.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

NY