End-stage Heart FailureNCT07534462
Echocardiographic Assessment of the Effect of Impella on Biventricular Function
An observational study of End-stage Heart Failure, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Heart Failure
- What is being tested?
- Echocardiographic Assessment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2026to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years) undergoing planned Impella 5.5 implantation at the University of Rochester Medical Center.
Who may be able to join
- Adult patients over 18 years old
- Require Impella 5.5 implantation
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
About this study
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.
Read the 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.
- Conditions
- End-stage Heart Failure
- Being tested
- Echocardiographic Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiographic AssessmentDiagnostic 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Echocardiographic Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14
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.
Measured: Baseline, immediately post-Impella initiation, and postoperative day up to Day14
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.
Measured: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14
Secondary outcomes (8)
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.
Measured: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14
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.
Measured: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14
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.
Measured: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14
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.
Measured: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14
Mean Change from Baseline in Right Ventricular End-Diastolic Volume (RVEDV)
Right ventricular end-diastolic volume will be measured using three-dimensional echocardiography.
Measured: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14
Mean Change from Baseline in Right Ventricular End-Systolic Volume (RVESV)
Right ventricular end-systolic volume will be measured using three-dimensional echocardiography.
Measured: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14
Mean Change from Baseline in Tricuspid Annular Plane Systolic Excursion (TAPSE)
Tricuspid annular plane systolic excursion will be measured using M-mode echocardiography and reflects right ventricular longitudinal systolic function. Higher values indicate better right ventricular function.
Measured: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14
Mean Change from Baseline in Right Ventricular Fractional Area Change (RV FAC)
Right ventricular fractional area change is calculated as the percentage change in right ventricular area between end-diastole and end-systole. Higher values indicate better right ventricular function.
Measured: Baseline, immediately post-Impella initiation, and postoperative day up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start11 Jul 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Heart FailureStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Principal investigator, Yoshihisa Morita, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534462
- Sponsor's protocol ID
- STUDY00010955
- Status last verified
- Sep 2026
- First submitted
- 9 Apr 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Assessment of the Effect of Impella on Biventricular Function
- ClinicalTrials.gov ID
- NCT07534462
- Acronym / sponsor ID
- STUDY00010955
- Conditions
- End-stage Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 11 Jul 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| End-stage heart failure patients receiving Impella 5.5 | – | Diagnostic Test: Echocardiographic AssessmentAdult patients with end-stage heart failure requiring Impella 5.5 for temporary mechanical circulatory support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) undergoing planned Impella 5.5 implantation at the University of Rochester Medical Center.
Key inclusion criteria (2 listed)
- Adult patients over 18 years old
- Require Impella 5.5 implantation
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiographic AssessmentEchocardiographic 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. | Diagnostic test | End-stage heart failure patients receiving Impella 5.5 |
Primary outcome
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
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.
Mean Change from Baseline in Left Ventricular Myocardial Work (MW
Time frame: Baseline, immediately post-Impella initiation, and postoperative day up to Day14
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.
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
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Heart Failure, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YOSHIHISA MORITA (585-275-2141, yoshihisa_morita@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.