All of Us Research Program
Do you want to change the future of health? The Froedtert & MCW health network is part of the National Institutes of Health All of Us Research Program. It has a simple mission — speed up health research breakthroughs. To do this, All of Us is asking one million people to share their health information. Learn how you can help make a difference by joining the All of Us Research Program.
The Organ Care System (OCS) Heart Perfusion Post-Approval Registry (OHP)
The objective of this post-approval registry is to provide additional real-world evidence of the performance of the OCS Heart System to preserve donor-after-brain-death (DBD) and donation-after-circulatory-death (DCD) donor hearts.
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).
The Organ Care System (OCS™) Lung Thoracic Organ Perfusion (TOP) Registry For Donor Lungs for Transplantation
The purpose of this project is to monitor the performance of the OCS™ Lung System and to collect additional clinical data from patients transplanted with donor lungs preserved using the TransMedics OCS™ Lung System for preservation of donor lungs for transplantation.