Clinical Use of the Impella RP System

Overview

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Patricia Best, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Patricia Best, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Clinical Trials