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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Patients 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.
Patients 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.
University Hospital Schleswig-Holstein
Lübeck, Germany
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.
Time frame: At the end of the catheter ablation procedure.
Number of participants with periprocedural adverse events
Periprocedural adverse events occurring during the catheter ablation procedure and throughout the index hospitalization will be recorded.
Time frame: Periprocedural (from initiation of the catheter ablation procedure until hospital discharge)
Procedural time
Procedural time
Time frame: At the end of catheter ablation procedure
Fluoroscopy time
Total fluoroscopy time (minutes) recorded during the catheter ablation procedure.
Time frame: End of 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.
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Time frame: End of the catheter ablation procedure
Number of participants requiring conversion from remote technical support to on-site technical support
The number of participants in whom the planned remote technical support could not be maintained and conversion to conventional on-site technical support was required because of technical or procedural reasons (only for interventional group)
Time frame: End of the catheter ablation procedure
Technical issues
Technical issues with the remote support system and technical issues with the augmented reality system
Time frame: At the end of catheter ablation procedure
Estimated carbon dioxide emissions associated with technical support
Estimated carbon dioxide (CO₂) emissions (kg CO₂ equivalent) associated with travel of field technical engineers to and from the participating study site. Emissions will be calculated from the recorded driving distance using a predefined standardized emission factor. In the remote support group, CO₂ emissions will be calculated based on the estimated distance the field technical engineers would drive if they would have to be on site.
Time frame: End of the catheter ablation procedure
Operator satisfaction with the procedural workflow assessed using 10-point numeric rating scales
Operator satisfaction with the procedural workflow will be assessed immediately after completion of the catheter ablation procedure using a 10-point numeric rating scale (NRS), where 0 indicates "not satisfied at all" and 10 indicates "completely satisfied."
Time frame: End of the catheter ablation procedure
Successful development of an artificial intelligence algorithm for analysis of recorded catheter ablation procedures to assess predefined procedural quality criteria
Feasibility will be assessed by whether the recorded procedural data from the intervention group are sufficient to develop an artificial intelligence (AI)-based algorithm capable of analyzing predefined procedural quality criteria . The outcome will be reported as successful or unsuccessful algorithm development according to predefined technical performance criteria.
Time frame: By completion of the AI algorithm development phase, up to 3 months after completion of data collection
Radiation dose
Total radiation exposure recorded during the catheter ablation procedure, reported as dose area product (DAP, Gy·cm²).
Time frame: End of the catheter ablation procedure
Number of participants requiring conversion from HoloLens-assisted remote support to conventional remote support
The number of participants in the intervention group in whom HoloLens-assisted remote technical support could not be maintained and support was continued using conventional remote communication without the Microsoft HoloLens headset because of technical or procedural reasons.
Time frame: End of the catheter ablation procedure
Driving time of field technical engineers
Driving time (minutes) required for field technical engineers to travel to and from the participating study site. For participants assigned to the remote support group, driving time will be estimated based on the hypothetical travel time that field technical engineers would have required had conventional on-site technical support been provided.
Time frame: End of the catheter ablation procedure
Driving distance of field technical engineers
Driving distance (kilometers) traveled by field technical engineers to and from the participating study site. For participants assigned to the remote support group, driving distance will be estimated based on the hypothetical distance that field technical engineers would have traveled had conventional on-site technical support been provided.
Time frame: End of the catheter ablation procedure
Field technical engineer satisfaction with the procedural workflow assessed using 10-point numeric rating scales
Field technical engineer satisfaction with the procedural workflow will be assessed immediately after completion of the catheter ablation procedure using a 10-point numeric rating scale (NRS), where 0 indicates "not satisfied at all" and 10 indicates "completely satisfied."
Time frame: End of the catheter ablation procedure
Successful development of an artificial intelligence algorithm for analysis of recorded catheter ablation procedures to generate automated procedural reports
Feasibility will be assessed by whether the recorded procedural data from the intervention group are sufficient to develop an artificial intelligence (AI)-based algorithm capable of generating automated procedural reports. The outcome will be reported as successful or unsuccessful algorithm development according to predefined technical performance criteria.
Time frame: By completion of the AI algorithm development phase, up to 3 moths after completion of data collection