Augmented Reality Aided Remote Access and Technical Support for Complex Ablation Procedures (HOLO-Remote)
16 de agosto de 2026 actualizado por: Roland Richard Tilz, MD, University of Luebeck
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Roland R Tilz, M.D.
- Número de teléfono: +49 451 500 44580
- Correo electrónico: tilz6@hotmail.de
Copia de seguridad de contactos de estudio
- Nombre: Sorin S Popescu, M.D.
- Número de teléfono: +49 451 500 77072
- Correo electrónico: sorin.popescu29@yahoo.ro
Ubicaciones de estudio
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Lübeck, Alemania, 23538
- University Hospital Schleswig-Holstein
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Contacto:
- Mirco Küchler
- Número de teléfono: +49 451 500 44542
- Correo electrónico: CTU.EP.LUEBECK@uksh.de
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: HoloLens Group
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).
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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.
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Comparador activo: On-site Group
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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Feasibility: Number of participants in whom remotely supported 3D electroanatomical mapping-based atrial fibrillation ablation is successfully completed
Periodo de tiempo: At the end of the catheter ablation procedure.
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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.
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At the end of the catheter ablation procedure.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of participants with periprocedural adverse events
Periodo de tiempo: Periprocedural (from initiation of the catheter ablation procedure until hospital discharge)
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Periprocedural adverse events occurring during the catheter ablation procedure and throughout the index hospitalization will be recorded.
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Periprocedural (from initiation of the catheter ablation procedure until hospital discharge)
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Procedural time
Periodo de tiempo: At the end of catheter ablation procedure
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Procedural time
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At the end of catheter ablation procedure
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Fluoroscopy time
Periodo de tiempo: End of the catheter ablation procedure
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Total fluoroscopy time (minutes) recorded during the catheter ablation procedure.
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End of the catheter ablation procedure
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Number of participants with successful completion of the intended catheter ablation procedure (the minimum procedural endpoint is successful pulmonary vein isolation)
Periodo de tiempo: End of the catheter ablation procedure
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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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End of the catheter ablation procedure
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Number of participants requiring conversion from remote technical support to on-site technical support
Periodo de tiempo: End of the catheter ablation procedure
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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)
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End of the catheter ablation procedure
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Technical issues
Periodo de tiempo: At the end of catheter ablation procedure
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Technical issues with the remote support system and technical issues with the augmented reality system
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At the end of catheter ablation procedure
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Estimated carbon dioxide emissions associated with technical support
Periodo de tiempo: End of the catheter ablation procedure
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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.
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End of the catheter ablation procedure
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Operator satisfaction with the procedural workflow assessed using 10-point numeric rating scales
Periodo de tiempo: End of the catheter ablation procedure
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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."
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End of the catheter ablation procedure
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Successful development of an artificial intelligence algorithm for analysis of recorded catheter ablation procedures to assess predefined procedural quality criteria
Periodo de tiempo: By completion of the AI algorithm development phase, up to 3 months after completion of data collection
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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.
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By completion of the AI algorithm development phase, up to 3 months after completion of data collection
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Radiation dose
Periodo de tiempo: End of the catheter ablation procedure
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Total radiation exposure recorded during the catheter ablation procedure, reported as dose area product (DAP, Gy·cm²).
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End of the catheter ablation procedure
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Number of participants requiring conversion from HoloLens-assisted remote support to conventional remote support
Periodo de tiempo: End of the catheter ablation procedure
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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.
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End of the catheter ablation procedure
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Driving time of field technical engineers
Periodo de tiempo: End of the catheter ablation procedure
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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.
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End of the catheter ablation procedure
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Driving distance of field technical engineers
Periodo de tiempo: End of the catheter ablation procedure
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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.
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End of the catheter ablation procedure
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Field technical engineer satisfaction with the procedural workflow assessed using 10-point numeric rating scales
Periodo de tiempo: End of the catheter ablation procedure
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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."
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End of the catheter ablation procedure
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Successful development of an artificial intelligence algorithm for analysis of recorded catheter ablation procedures to generate automated procedural reports
Periodo de tiempo: By completion of the AI algorithm development phase, up to 3 moths after completion of data collection
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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.
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By completion of the AI algorithm development phase, up to 3 moths after completion of data collection
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Roland R Tilz, M.D., University of Lübeck, Department of Rhythmology
- Investigador principal: Sorin S Popescu, M.D., University of Lübeck, Department of Rhythmology
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
1 de febrero de 2028
Finalización del estudio (Estimado)
1 de febrero de 2028
Fechas de registro del estudio
Enviado por primera vez
5 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
16 de agosto de 2026
Publicado por primera vez (Actual)
20 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
16 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025-221
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Data supporting the study are curated at the Clinical Trial Unit of the Department of Rhythmology, University Hospital Schleswig-Holstein, Lübeck, Germany.
These data are not shared openly but are available on reasonable request from the corresponding authors.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .