Echocardiographic Assessment of the Effect of Impella on Biventricular Function
ConditionEnd-stage Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Rochester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients over 18 years old
Require Impella 5.5 implantation
Disqualifiers
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
Trial population
Adult patients (≥18 years) undergoing planned Impella 5.5 implantation at the University of Rochester Medical Center.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Echocardiographic Assessment
Diagnostic testEchocardiographic 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.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: End-stage heart failure patients receiving Impella 5.51 intervention
Trial outcomes
Primary outcomes
1
Mean Change from Baseline in Left Ventricular Global Longitudinal Strain (LV GLS)
Left ventricular global longitudinal strain will be measured using speckle-tracking echocardiography from transesophageal and transthoracic images. LV endocardial borders are manually traced, and strain is calculated as the average peak systolic longitudinal strain across left ventricular segments. Values are expressed as percentage. More negative values indicate better myocardial function.
Time frame
Baseline, immediately post-Impella initiation, and postoperative day up to Day 142
Mean Change from Baseline in Left Ventricular Myocardial Work (MW
Left ventricular myocardial work will be calculated using pressure-strain loop analysis derived from echocardiographic strain data combined with non-invasive blood pressure measurements using EchoPac software. Higher values indicate improved myocardial performance.
Time frame
Baseline, immediately post-Impella initiation, and postoperative day up to Day143
Mean Change from Baseline in Right Ventricular Global Longitudinal Strain (RV GLS)
Right ventricular global longitudinal strain will be measured using speckle-tracking echocardiography from apical or transesophageal four-chamber views. RV free wall segments are analyzed and averaged to determine strain. Values are expressed as percentage. More negative values indicate better myocardial function.
Time frame
Baseline, immediately post-Impella initiation, and postoperative day up to Day 14Secondary outcomes
1
Mean Change from Baseline in Left Ventricular Ejection Fraction (LVEF)
Left ventricular ejection fraction will be measured using three-dimensional echocardiographic imaging and automated quantification software. Higher values indicate better ventricular function.
Time frame
Baseline, immediately post-Impella initiation, and postoperative day up to Day 142
Mean Change from Baseline in Left Ventricular End-Diastolic Volume (LVEDV)
Left ventricular end-diastolic volume will be measured using three-dimensional echocardiography and represents the volume of blood in the left ventricle at end-diastole.
Time frame
Baseline, immediately post-Impella initiation, and postoperative day up to Day 143
Mean Change from Baseline in Left Ventricular End-Systolic Volume (LVESV)
Left ventricular end-systolic volume will be measured using three-dimensional echocardiography and represents the volume of blood remaining in the ventricle after contraction.
Time frame
Baseline, immediately post-Impella initiation, and postoperative day up to Day 144
Mean Change from Baseline in Right Ventricular Ejection Fraction (RVEF)
Right ventricular ejection fraction will be assessed using three-dimensional echocardiographic imaging. Higher values indicate better ventricular function.
Time frame
Baseline, immediately post-Impella initiation, and postoperative day up to Day 14Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Rochester
Lead sponsor
Johnson & Johnson
Collaborator
Source ClinicalTrials.gov