Augmented Reality Aided Remote Access and Technical Support for Complex Ablation Procedures (HOLO-Remote)
16 августа 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Условия
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
60
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Roland R Tilz, M.D.
- Номер телефона: +49 451 500 44580
- Электронная почта: tilz6@hotmail.de
Учебное резервное копирование контактов
- Имя: Sorin S Popescu, M.D.
- Номер телефона: +49 451 500 77072
- Электронная почта: sorin.popescu29@yahoo.ro
Места учебы
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Lübeck, Германия, 23538
- University Hospital Schleswig-Holstein
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Контакт:
- Mirco Küchler
- Номер телефона: +49 451 500 44542
- Электронная почта: CTU.EP.LUEBECK@uksh.de
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Активный компаратор: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Feasibility: Number of participants in whom remotely supported 3D electroanatomical mapping-based atrial fibrillation ablation is successfully completed
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of participants with periprocedural adverse events
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Roland R Tilz, M.D., University of Lübeck, Department of Rhythmology
- Главный следователь: Sorin S Popescu, M.D., University of Lübeck, Department of Rhythmology
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 августа 2026 г.
Первичное завершение (Оцененный)
1 февраля 2028 г.
Завершение исследования (Оцененный)
1 февраля 2028 г.
Даты регистрации исследования
Первый отправленный
5 августа 2026 г.
Впервые представлено, что соответствует критериям контроля качества
16 августа 2026 г.
Первый опубликованный (Действительный)
20 августа 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
20 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
16 августа 2026 г.
Последняя проверка
1 августа 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2025-221
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана 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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .