Augmented Reality Aided Remote Access and Technical Support for Complex Ablation Procedures (HOLO-Remote)
sunnuntai 16. elokuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
60
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Roland R Tilz, M.D.
- Puhelinnumero: +49 451 500 44580
- Sähköposti: tilz6@hotmail.de
Tutki yhteystietojen varmuuskopiointi
- Nimi: Sorin S Popescu, M.D.
- Puhelinnumero: +49 451 500 77072
- Sähköposti: sorin.popescu29@yahoo.ro
Opiskelupaikat
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Lübeck, Saksa, 23538
- University Hospital Schleswig-Holstein
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Ottaa yhteyttä:
- Mirco Küchler
- Puhelinnumero: +49 451 500 44542
- Sähköposti: CTU.EP.LUEBECK@uksh.de
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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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Active Comparator: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Feasibility: Number of participants in whom remotely supported 3D electroanatomical mapping-based atrial fibrillation ablation is successfully completed
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of participants with periprocedural adverse events
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Roland R Tilz, M.D., University of Lübeck, Department of Rhythmology
- Päätutkija: Sorin S Popescu, M.D., University of Lübeck, Department of Rhythmology
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
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Tutkimustietojen päivitykset
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Viimeksi vahvistettu
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Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2025-221
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
EI
IPD-suunnitelman kuvaus
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.
Lääke- ja laitetiedot, tutkimusasiakirjat
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