Conformal Medical, Inc. has launched the GLACE Study, a European clinical trial designed to evaluate the use of intracardiac echocardiography (ICE) imaging for left atrial appendage (LAA) closure in patients with non-valvular atrial fibrillation.

The study, which will enroll around 80 patients across Denmark, Italy, and the Czech Republic, will test the next-generation CLAAS® AcuFORM™ device.

The first patients in the study were treated by leading investigators from Denmark, including experts from Aarhus University Hospital and Copenhagen University Hospital. Additionally, Dr. Shephal Doshi, a key figure in the ongoing CONFORM Pivotal Trial in the U.S., was present to support these initial procedures.

This new generation of the CLAAS AcuFORM device brings significant improvements in simplifying the procedure, including its ability to conform to a wide range of LAA anatomies with just two device sizes.

This design helps reduce the complexity of treatment, while ICE imaging enables real-time visualization of cardiac structures. The use of ICE also offers benefits like less radiation exposure, shorter procedure times, and eliminating the need for general anesthesia, ultimately making the process more comfortable for patients and efficient for medical teams.

By refining the procedure to work without the need for general anesthesia or transesophageal echocardiography (TEE), the CLAAS AcuFORM system could transform the way LAA closure is performed, allowing for same-day, single-operator procedures. To date, over 350 patients have already been treated successfully with this system in previous feasibility studies and trials.

The GLACE Study marks an important step in expanding the use of ICE imaging in LAA closure, helping to simplify and streamline treatment options for atrial fibrillation patients worldwide.





Source: conformalmedical.com

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