Augmented Reality Aided Remote Access and Technical Support for Complex Ablation Procedures

Sponsor
University of Luebeck
Study ID
NCT07777042
Status
Not Yet Recruiting

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Conditions

  • Atrial Fibrillation (AF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HoloLens supported catheter ablation — PROCEDURE
    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.
  • On-site supported catheter ablation — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Aug 20, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).
  • 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.

Primary Outcome Measure

Feasibility: Number of participants in whom remotely supported 3D electroanatomical mapping-based atrial fibrillation ablation is successfully completed [ Time Frame: At the end of the catheter ablation procedure. ]

Central Contacts

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