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Clinical Trials

Topic   Cardiology
Title   IMPELLA RP® Circulatory Support System
Summary   The Impella® RP Catheter is a blood pump that is placed within the heart for up to to assist blood circulation when the ability of the heart to pump blood is weakened. It can be used on adults and children with certain heart conditions, and is considered a Humanitarian Use Device (HUD) by the FDA, which means it is approved for use, in very rare situations, even though the effectiveness of the device is not fully known.
Description   The Impella® RP Catheter is a blood pump placed inside the heart that supports a patient’s pulmonary (lung) circulation. It is inserted percutaneously (through the skin) through the femoral (groin) vein and into the pulmonary artery. Patients (pediatric or adult) who require assistance with their blood circulation, due to a weakened heart can have this device placed for up to 14 days. The patient must have a body surface area greater than or equal to 1.5 m2. To be eligible the patient must have a weakened heart condition can due to acute (recently developed) right sided heart failure or decompensation (deterioriation) after implantation of a left ventricular (left chamber of the heart) assist device, a myocardial infarction (heart attack), heart transplant, or open-heart surgery. Impella is classified as a Humanitarian Use Device, (HUD) by the Food and Drug Administration (FDA). A HUD is approved for use, even though its use is not technically research. HUD is a special FDA category for devices that are used to help patients with rare conditions, those that happen to less than 4,000 people in the US each year. Exactly how effective it is or what the long term effects are is not fully known.
IRB Number   15321
Inclusion/Notes   Pediatric or adult patients who have developed recent right heart failure or decompensation after implantation of a left ventricular assist device, myocardial infarction, heart transplant, or open-heart surgery.
Principal Name   Srihari Naidu, MD
Contact Name   Wendy Drewes, BSN, RN, CCRC, Dipti Patel, MSN, MPH
Email   wdrewes@nyuwinthrop.org, dpatel@nyuwinthrop.org
Phone   516-663-2929
Alternate Phone   516-663-8692