Augmented Reality Aided Remote Access and Technical Support for Complex Ablation Procedures (HOLO-Remote)
16 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Roland R Tilz, M.D.
- Telefonnummer: +49 451 500 44580
- E-post: tilz6@hotmail.de
Studera Kontakt Backup
- Namn: Sorin S Popescu, M.D.
- Telefonnummer: +49 451 500 77072
- E-post: sorin.popescu29@yahoo.ro
Studieorter
-
-
-
Lübeck, Tyskland, 23538
- University Hospital Schleswig-Holstein
-
Kontakt:
- Mirco Küchler
- Telefonnummer: +49 451 500 44542
- E-post: CTU.EP.LUEBECK@uksh.de
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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).
|
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.
|
|
Aktiv komparator: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Feasibility: Number of participants in whom remotely supported 3D electroanatomical mapping-based atrial fibrillation ablation is successfully completed
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of participants with periprocedural adverse events
Tidsram: 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
Tidsram: At the end of catheter ablation procedure
|
Procedural time
|
At the end of catheter ablation procedure
|
|
Fluoroscopy time
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Roland R Tilz, M.D., University of Lübeck, Department of Rhythmology
- Huvudutredare: Sorin S Popescu, M.D., University of Lübeck, Department of Rhythmology
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 augusti 2026
Primärt slutförande (Beräknad)
1 februari 2028
Avslutad studie (Beräknad)
1 februari 2028
Studieregistreringsdatum
Först inskickad
5 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
16 augusti 2026
Första postat (Faktisk)
20 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025-221
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .