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Augmented Reality Aided Remote Access and Technical Support for Complex Ablation Procedures (HOLO-Remote)

16 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Roland R Tilz, M.D.
  • Telefoonnummer: +49 451 500 44580
  • E-mail: tilz6@hotmail.de

Studie Contact Back-up

Studie Locaties

  • Duitsland
      • Lübeck, Duitsland, 23538
        • University Hospital Schleswig-Holstein
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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).
Procedure: HoloLens 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.
Actieve vergelijker: 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.
Procedure: On-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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Feasibility: Number of participants in whom remotely supported 3D electroanatomical mapping-based atrial fibrillation ablation is successfully completed
Tijdsspanne: 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.
At the end of the catheter ablation procedure.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of participants with periprocedural adverse events
Tijdsspanne: 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.
Periprocedural (from initiation of the catheter ablation procedure until hospital discharge)
Procedural time
Tijdsspanne: At the end of catheter ablation procedure
Procedural time
At the end of catheter ablation procedure
Fluoroscopy time
Tijdsspanne: End of the catheter ablation procedure
Total fluoroscopy time (minutes) recorded during the catheter ablation procedure.
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)
Tijdsspanne: 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.
End of the catheter ablation procedure
Number of participants requiring conversion from remote technical support to on-site technical support
Tijdsspanne: 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)
End of the catheter ablation procedure
Technical issues
Tijdsspanne: At the end of catheter ablation procedure
Technical issues with the remote support system and technical issues with the augmented reality system
At the end of catheter ablation procedure
Estimated carbon dioxide emissions associated with technical support
Tijdsspanne: 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.
End of the catheter ablation procedure
Operator satisfaction with the procedural workflow assessed using 10-point numeric rating scales
Tijdsspanne: 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."
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
Tijdsspanne: 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.
By completion of the AI algorithm development phase, up to 3 months after completion of data collection
Radiation dose
Tijdsspanne: End of the catheter ablation procedure
Total radiation exposure recorded during the catheter ablation procedure, reported as dose area product (DAP, Gy·cm²).
End of the catheter ablation procedure
Number of participants requiring conversion from HoloLens-assisted remote support to conventional remote support
Tijdsspanne: 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.
End of the catheter ablation procedure
Driving time of field technical engineers
Tijdsspanne: 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.
End of the catheter ablation procedure
Driving distance of field technical engineers
Tijdsspanne: 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.
End of the catheter ablation procedure
Field technical engineer satisfaction with the procedural workflow assessed using 10-point numeric rating scales
Tijdsspanne: 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."
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
Tijdsspanne: 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.
By completion of the AI algorithm development phase, up to 3 moths after completion of data collection

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Luebeck

Onderzoekers

  • Hoofdonderzoeker: Roland R Tilz, M.D., University of Lübeck, Department of Rhythmology
  • Hoofdonderzoeker: Sorin S Popescu, M.D., University of Lübeck, Department of Rhythmology

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

1 februari 2028

Studie voltooiing (Geschat)

1 februari 2028

Studieregistratiedata

Eerst ingediend

5 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

16 augustus 2026

Eerst geplaatst (Werkelijk)

20 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

16 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2025-221

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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