Atrial Fibrillation (AF)
Conditions
Keywords
Atrial fibrillation, Remote access and technical support, Augmented reality, 3D electroanatomical mapping, Catheter ablation
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREHoloLens supported catheter ablation
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.
PROCEDUREOn-site supported catheter ablation
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.
Sponsors
University of Luebeck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients enrolled in the study and randomized in a 1:1 fashion.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Number of participants in whom remotely supported 3D electroanatomical mapping-based atrial fibrillation ablation is successfully completed | At the end of the catheter ablation procedure. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Driving distance of field technical engineers | End of the catheter ablation procedure | 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. |
| Number of participants with periprocedural adverse events | Periprocedural (from initiation of the catheter ablation procedure until hospital discharge) | Periprocedural adverse events occurring during the catheter ablation procedure and throughout the index hospitalization will be recorded. |
| Procedural time | At the end of catheter ablation procedure | Procedural time |
| Fluoroscopy time | End of the catheter ablation procedure | 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) | End of the catheter ablation procedure | 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. |
| Number of participants requiring conversion from remote technical support to on-site technical support | End of the catheter ablation procedure | 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) |
| Technical issues | At the end of catheter ablation procedure | Technical issues with the remote support system and technical issues with the augmented reality system |
| Estimated carbon dioxide emissions associated with technical support | End of the catheter ablation procedure | 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. |
| Operator satisfaction with the procedural workflow assessed using 10-point numeric rating scales | End of the catheter ablation procedure | 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." |
| Successful development of an artificial intelligence algorithm for analysis of recorded catheter ablation procedures to assess predefined procedural quality criteria | By completion of the AI algorithm development phase, up to 3 months after completion of data collection | 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. |
| Radiation dose | End of the catheter ablation procedure | Total radiation exposure recorded during the catheter ablation procedure, reported as dose area product (DAP, Gy·cm²). |
| Number of participants requiring conversion from HoloLens-assisted remote support to conventional remote support | End of the catheter ablation procedure | 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. |
| Driving time of field technical engineers | End of the catheter ablation procedure | 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. |
| Field technical engineer satisfaction with the procedural workflow assessed using 10-point numeric rating scales | End of the catheter ablation procedure | 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." |
| Successful development of an artificial intelligence algorithm for analysis of recorded catheter ablation procedures to generate automated procedural reports | By completion of the AI algorithm development phase, up to 3 moths after completion of data collection | 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. |
Countries
Germany
Contacts
CONTACTRoland R Tilz, M.D.
CONTACTSorin S Popescu, M.D.
PRINCIPAL_INVESTIGATORRoland R Tilz, M.D.
University of Lübeck, Department of Rhythmology
PRINCIPAL_INVESTIGATORSorin S Popescu, M.D.
University of Lübeck, Department of Rhythmology
Outcome results
None listed