Echocardiographic Assessment of the Effect of Impella on Biventricular Function
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Echocardiographic Assessment.
- Who it may be relevant to
- Registry conditions: End-stage Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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 up to 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.
Interventions
- Diagnostic test Echocardiographic Assessment
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.
Primary outcome measures
- 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]
- Mean Change from Baseline in Left Ventricular Myocardial Work (MW [Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day14]
- Mean Change from Baseline in Right Ventricular Global Longitudinal Strain (RV GLS) [Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14]
Secondary outcome measures (8)
- Mean Change from Baseline in Left Ventricular Ejection Fraction (LVEF) [Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14]
- Mean Change from Baseline in Left Ventricular End-Diastolic Volume (LVEDV) [Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14]
- Mean Change from Baseline in Left Ventricular End-Systolic Volume (LVESV) [Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14]
- Mean Change from Baseline in Right Ventricular Ejection Fraction (RVEF) [Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14]
- Mean Change from Baseline in Right Ventricular End-Diastolic Volume (RVEDV) [Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14]
- Mean Change from Baseline in Right Ventricular End-Systolic Volume (RVESV) [Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14]
- Mean Change from Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE) [Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14]
- Mean Change from Baseline in Right Ventricular Fractional Area Change (RV FAC) [Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14]
Eligibility criteria
Inclusion criteria
- Adult patients over 18 years old
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07534462 · STUDY00010955