Impella Pump Return Study to Analyze Deposits and Biomaterial in Used Pumps
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbiomed Inc.
About this trial
Analysis of cell and protein deposits on the Impella Heart Pump.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with Impella 5.5 therapy and duration of support for ≥ 25 days OR Patients with Impella CP therapy and duration of support for > 4 days
Disqualifiers
Age < 18 years
Trial population
Patients treated with Impella CP or Impella 5.5 heart pump due to severe acute heart failure by any cause (e.g. cardiogenic shock in acute myocardial infarction, cardiac arrest, myocarditis or in relation to cardiac surgery).
Trial design
Design model
Other
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: Impella CP
Group B: Impella 5.5
Trial outcomes
Primary outcomes
1
Investigate deposits and biomaterial after use of pump
investigate Impella CP after use regarding deposits and biomaterial
Time frame
through study completion, at least 5 days2
Investigate deposits and biomaterial after use of pump
investigate Impella 5.5 pumps after use regarding deposits and biomaterial
Time frame
through study completion, at least 25 daysSecondary outcomes
1
Relation deposits and biomaterial to clinical events
By correlating patient data, such as medical history and Impella CP related blood parameters, with the findings from our pump analysis, potential connections between medication, diseases, comorbidities, and deposits on the pump can be identified.
Time frame
through study completion, at least 5 days2
Relation deposits and biomaterial to clinical events
By correlating patient data, such as medical history and Impella 5.5 related blood parameters, with the findings from our pump analysis, potential connections between medication, diseases, comorbidities, and deposits on the pump can be identified.
Time frame
through study completion, at least 25 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov