Conformal Medical Inc, a US-based medical device company developing devices to prevent stroke in patients with non-valvular atrial fibrillation, announced on Tuesday the launch of the GLACE study.
Conducted in Europe, the study is intended to evaluate the use of intracardiac echocardiography (ICE) imaging of the left atrial appendage (LAA) in appendage closure procedures with the next-generation CLASS AcuForm device in patients with non-valvular atrial fibrillation.
The prospective, multicentre, non-randomised, single-arm investigation will enrol around 80 patients in Denmark, Italy and the Czech Republic.
Professor Jens Erik Nielsen-Kudsk, MD of Aarhus University Hospital, said: "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. ICE has become our primary imaging platform for LAAO, the GLACE study allows us to validate the use of ICE with this innovative technology."
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