Clinical Use of the Impella RP System

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 15-009193
    Sponsor Protocol Number: 15-009193

About this study

This Is a Humanitarian Use Protocol for the Impella RP® System which is indicated for providing circulatory assistance for up to 14 days in pediatric or adult patients with a body surface area ≥ 1.5 m2 who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Adult patients with a body surface area ≥ 1.5 m2 who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. 

Exclusion Criteria:

  • Disorders of the pulmonary artery wall that would preclude placement or correct positioning of the Impella RP® device
  • Mechanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid valve or pulmonary valve
  • Mural thrombus of the right atrium or vena cava
  • Anatomic conditions precluding insertion of the pump
  • Other illnesses or therapy requirements precluding use of the pump
  • Presence of a vena caval filter or caval interruption device, unless there is clear access from the femoral vein to the right atrium that is large enough to accommodate a 22 Fr catheter

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Patricia Best, M.D.

Contact us for the latest status

Contact information:

Patricia Best M.D.

(507)284-1644

best.patricia@mayo.edu

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CLS-20308311

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