Clinical Trials

Inclusion Criteria:

• Subjects requiring mechanical circulatory support of either:

  • Extracorporeal membrane oxygenation support (ECMO) including V-A, V-V and V-A-V circuits.

  • Ventricular assist devices (VADs), including long-term durable VADs and short term percutaneous VADs (pVAD e.g. Impella, TandemHeart) using an axial or centrifugal flow pump, with pulsatile or continuous flow technology.

• Ability to obtain written consent from subject or legally authorized representative. In cases where IRB approval for waiver of consent/assent is granted, consent/assent will not be obtained, and procedures will follow IRB-approved waiver conditions.

• Subjects from whom adequate blood sample volume can be drawn

Exclusion Criteria:

• Subjects with conditions considered by their healthcare provider to put them at increased health risk if they provide a blood sample.

• Subjects whose maximum blood draw volume based on weight are already reached (especially for neonates and infants).

• Subjects for whom an informed consent or assent cannot be completed and IRBapproved waiver is not implemented.

• Judgment by the investigator that the participant should not participate in the study under medical conditions.

• Female subjects who are pregnant

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 02/15/2026. Questions regarding updates should be directed to the study team contact.