Conformal Medical, Inc. today announced the initiation of the GLACE Study. This European study* aims to assess the use of intracardiac echocardiography (ICE) imaging of the left atrial appendage (LAA) during appendage closure procedures with the next-generation CLAAS® AcuFORM™ device in patients with non-valvular atrial fibrillation. The prospective, multicenter, non-randomized, single-arm investigation will enroll approximately 80 patients in Denmark, Italy, and the Czech Republic.
Initial patients were treated by the study’s co-principal investigators Professor Jens Erik Nielsen-Kudsk, M.D. of Aarhus University Hospital and Professor Ole De Backer, M.D. of Rigshospitalet, Copenhagen University Hospital at their respective institutions in Denmark. Additionally, Shephal Doshi, M.D., from Providence Saint John’s Health Center and the Pacific Heart Institute in Santa Monica, California and Principal Investigator of the CONFORM Pivotal Trial was present for the initial cases.
“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,” stated Nielsen-Kudsk. “ICE has become our primary imaging platform for LAAO, the GLACE Study allows us to validate the use of ICE with this innovative technology.”
ICE imaging facilitates real-time visualization of cardiac structures during LAAO closure, enhancing precision while reducing radiation exposure and procedure time. This approach often eliminates the need for general anesthesia, improving patient comfort and operational efficiency.
“The CLAAS AcuFORM device enhances and simplifies the procedure, with only two sizes, one of which effectively treats over 90% of patients,” stated Dr. Doshi. “Simplified sizing and ease of use enabled by this device will drive improved workflow in the lab.”
Designed to optimize anchor penetration and featuring an improved ePTFE material, and a simplified delivery system, the CLAAS AcuFORM LAAO System builds upon the novel CLAAS device and is engineered to conform to and seal the LAA with its proprietary foam-based architecture. The implant addresses the clinical spectrum of LAA anatomies with only two sizes. The system aims to simplify delivery and eliminate the need for procedural transesophageal echocardiogram (TEE) so that physicians may perform the procedure without general anesthesia, a significant advancement with the potential to shift clinical practice to a same-day, single-operator procedure. Over 350 patients have been successfully implanted with the Conformal CLAAS System as part of early feasibility studies and the ongoing CONFORM Pivotal Trial.
“The use of ICE imaging in LAAO is growing significantly and will continue,” said James Reinstein, President and CEO of Conformal Medical. “Our next-generation LAAO technology conforms to individual anatomies, enabling clinicians to simplify the procedure with 2 sizes, the ability to confirm seal, and eliminate general anesthesia & intubation.”