Augmented Reality Aided Remote Access and Technical Support for Complex Ablation Procedures

Augmented Reality Aided Remote Access and tecHnical suppOrt for compLex ablatiOn Procedures

Prospective, randomized, controlled, single-center pilot study evaluating the feasibility and safety of augmented reality-based remote technical support using the Microsoft HoloLens and EnSite™ Connected Care compared with conventional on-site support during 3D electroanatomical mapping-guided electrophysiological procedures. The study also assesses the feasibility of an AI-based algorithm integrated into the Medinbox Link system for automated procedural report generation and detection of protocol deviations from standard clinical practice.

Prospective, randomized, controlled, monocentric, pilot study to evaluate the feasibility and safety of remote access and technical support using an augmented reality system (Microsoft HoloLens headset) in association with the EnSite™ Connected Care solution (EnSite™ Connect Remote Support, Abbott and Medinbox system, Medinbox) as compared to the on-site support for three-dimensional (3D) electroanatomical mapping-based electrophysiological (EP) procedures. Moreover, the study will evaluate the feasibility of an artificial intelligence (AI)-based algorithm integrated within the Medinbox Link system (Medinbox) to analyse video and audio recordings obtained during the procedure, with the aim of automatically generating procedural reports and identifying protocol deviations from the standard of care.

Inclusion Criteria:

• Patients age ≥ 18 years
• Indication for 3D electroanatomical mapping-based catheter ablation for the treatment of AF
• Signed written informed consent

Exclusion Criteria:

• Patient is unable or unwilling to provide informed consent
• Patient is included in another randomised clinical trial
• Inability to comply with the study procedures