Conformal Launches European GLACE Study of Next-Generation CLAAS AcuForm LAAO Device

October 1, 2024— Conformal Medical, Inc. announced the initiation of the GLACE Study. According to the company, the European study aims to assess the use of intracardiac echocardiography (ICE) imaging of the left atrial appendage (LAA) during appendage closure procedures with the Conformal next-generation CLAAS AcuForm device in patients with nonvalvular atrial fibrillation. The prospective, multicenter, nonrandomized, single-arm investigation will enroll approximately 80 patients in Denmark, Italy, and the Czech Republic.

The company advised that the first patients in the GLACE study were treated by coprincipal investigators Professor Jens Erik Nielsen-Kudsk, MD, of Aarhus University Hospital in Aarhus, Denmark, and Professor Ole De Backer, MD, of Rigshospitalet, Copenhagen University Hospital in Copenhagen, Denmark, at their respective institutions.

“I am excited about the new CLAAS AcuForm implant and the ability to confirm seal with angiography providing procedural confidence, ensuring the patient has been properly treated,” commented Prof. Nielsen-Kudsk in the company’s press release. “ICE has become our primary imaging platform for LAAO, the GLACE Study allows us to validate the use of ICE with this innovative technology.”

Shephal Doshi, MD, the principal investigator of the United States CONFORM pivotal trial, was present for the initial cases in the European study. Dr. Doshi is from Providence Saint John’s Health Center and the Pacific Heart Institute in Santa Monica, California.

Dr. Doshi stated in the press release, “The CLAAS AcuForm device enhances and simplifies the procedure, with only two sizes, one of which effectively treats over 90% of patients. Simplified sizing and ease of use enabled by this device will drive improved workflow in the lab.”