Echocardiographic Assessment of the Effect of Impella on Biventricular Function
ConditionEnd-stage Heart Failure
Trial statusNot yet recruiting
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
Qualifiers
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 design
Treatments tested in this trial
- Echocardiographic Assessment
Treatment groups
24 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
University of Rochester
Lead sponsor
Johnson & Johnson
Collaborator
Source ClinicalTrials.gov