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GLACE Study

The European GLACE Study is a prospective,
multi-center, non-randomized study designed to evaluate the CLAAS® AcuFORM™ System with the use of intracardiac echocardiography (ICE) imaging of the Left Atrial Appendage during Appendage Closure (LAAC) implant procedure for subjects with non-valvular atrial fibrillation to reduce stroke.

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All patients enrolled in the GLACE Study will receive the Conformal next-gen CLAAS® AcuFORM™ LAAO device.

 

CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use. Not for sale in any geography.

 

Study designed to comply with  EU MDR Chapter VI, Article 62 4(i)

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A New Device for Treating The Left Atrial Appendage

The CLAAS® AcuFORM™ System builds upon the novel CLAAS device, and is engineered to conform to and seal the LAA. 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. The device is permanently placed in the heart by your physician during a single procedure.

Study Participants

Please contact your physician or enrolling site coordinator for a full list of eligibility criteria. Prior to participating, the clinical staff will review the study risks and benefits and address your questions as part of the informed consent process. As part of the study, you’ll have several responsibilities.

 

Eligibility Requirements

  • Diagnosed with non-valvular atrial fibrillation

  • At an increased risk of stroke and recommended for oral anticoagulation

  • Willing to comply with study protocol, including medication regime and follow-up evaluations

 

Participant Responsibilities

      • Provide informed consent 

      • Adhere to antiplatelet and/or oral anticoagulant therapy

    • Comment to specific follow-up intervals 

How It Works

The CLAAS® implant has been designed to reduce the risk of thromboembolism from the left atrial appendage in patients
with non-valvular atrial fibrillation.

Clinical Studies

The CLAAS System is being studied in the following clinical trials. 


Data from the EFS and Prague studies have been published in peer-reviewed articles. The CLAAS device is limited to investigational use only and is not approved for use in any geography.

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