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.
Patients age ≥ 18 years
Indication for 3D electroanatomical mapping-based catheter ablation for the treatment of AF
Signed written informed consent
Patient is unable or unwilling to provide informed consent
Patient is included in another randomised clinical trial
Inability to comply with the study procedures
Parallel
HoloLens supported catheter ablation
Procedure/SurgeryPatients undergoing 3D electroanatomical mapping-based AF ablation procedures using the EnSite™ X EP System operated remotely by means of the EnSite™ Connected Care solution (EnSite™ Connect Remote Support, Abbott and Medinbox system, Medinbox) and the Microsoft HoloLens (Microsoft). The HoloLens headset will be implemented to facilitate the communication between the principal operator and the FTE (working in Home Office). The FTE will not be present on site.
On-site supported catheter ablation
Procedure/SurgeryPatients undergoing 3D electroanatomical mapping-based AF ablation procedures using the EnSite™ X EP System operated by the FTE on site, in the Minimal Invasive Centre (MIC) of the hospital. The HoloLens headset and the EnSite™ Connected Care solution will not be used. The communication between the operator (in the operating room) and the FTE (in the control room) will be established by means of radio-based headphones.
Feasibility: Number of participants in whom remotely supported 3D electroanatomical mapping-based atrial fibrillation ablation is successfully completed
Feasibility will be assessed as the number and percentage of participants in whom the planned 3D electroanatomical mapping-guided atrial fibrillation ablation procedure is successfully completed using remote technical support provided through an augmented reality system (Microsoft HoloLens headset) in conjunction with the EnSite™ Connected Care solution (EnSite™ Connect Remote Support, Abbott) and the Medinbox system. Successful completion is defined as completion of the planned mapping and ablation procedure without conversion to on-site technical support because of technical failure of the remote support system.
Number of participants with periprocedural adverse events
Periprocedural adverse events occurring during the catheter ablation procedure and throughout the index hospitalization will be recorded.
Procedural time
Procedural time
Fluoroscopy time
Total fluoroscopy time (minutes) recorded during the catheter ablation procedure.
Number of participants with successful completion of the intended catheter ablation procedure (the minimum procedural endpoint is successful pulmonary vein isolation)
Procedural success will be assessed as successful completion of the intended catheter ablation procedure. A minimum procedural endpoint is successful pulmonary vein isolation (PVI), confirmed by entrance block in all pulmonary veins. Additional ablations may be performed at the operator's discretion based on the patient's clinical characteristics and the planned treatment strategy. When additional ablations are planned or performed, procedural success also requires successful completion of these additional lesion sets according to the predefined procedural objectives.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
