Extracorporeal Membrane Oxygenation (ECMO) is used for heart and lung support. While ECMO is widely considered the standard of care for children with severe cardiac failure requiring emergent life support, no ECMO circuit has ever been FDA-approved or cleared for children.
Why the Cardiohelp System?
In recent years, a growing number of U.S. children’s hospitals have moved to a single standardized ECMO circuit known as the Cardiohelp System. The Cardiohelp System is a portable compact, complete cardiopulmonary system that is FDA-cleared for cardiopulmonary bypass in adults but not children. However, it's not cleared for ECMO in adults or children. TROLLEY is a multicenter study to formally evaluate device safety and effectiveness for up to 30 days of support in a group of children and infants.
What will we learn from TROLLEY?
The primary goal is to generate the data necessary to secure FDA-clearance of the first complete ECMO circuit in children with cardiac failure. A secondary goal is to evaluate the safety and effectiveness of heparin vs. bivalirudin as the primary blood thinner for children on ECMO who are supported with the Cardiohelp system.
The TROLLEY study is funded by U.S. Food and Drug Administration, Office of Orphan Products Development, #1R01FD 0078833-01A1. To learn more, visit clinicaltrials.gov, Clinical Trials Number NCT06080074, Multicenter Trial of ECMO for Children with Severe Cardiac Failure Using the Cardiohelp System.