CentriMAG Failure to Wean Post Approval Study


As part of heart surgery, patients are put on cardiopulmonary bypass, a machine that temporarily takes over the function of the heart and lungs during surgery, maintaining circulation of blood and oxygen to the rest of the body. In some cases, patients are not able to get off bypass, and their heart is not able to spontaneously contract to allow for normal blood circulation. The CentriMag Circulatory Support System provides support to these patients, if needed. The CentriMag system, supports the heart and moves blood through the circulatory system until the patient’s heart recovers, is transplanted, or needs long term mechanical circulatory support. The purpose of this research study is to continue monitoring and collecting data for patients who require the CentriMag Circulatory Support System. The CentriMag Circulatory Support System has been approved by the FDA and is currently in commercial use. It is therefore not an investigational device. This study is required by the FDA for continued data collection for patients who are implanted with the device for up to 30 days post-explant or discharge, whichever time point is longer. If you are not able to be taken off the device, follow-up will last until start of anesthesia for another medical intervention (a heart transplant or long-term device).

Primary Investigator: Lucian Durham, MD, PhD
Subinvestigators: Lyle Joyce, MD, PhD; Takushi Kohmoto, MD, PhD; Adam Ubert, MD; Paul Pearson, MD, PhD

ClinicalTrials.gov Identifier: NCT04464785
Status: Currently Enrolling

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