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NOT YET RECRUITING
NCT07777042
NA

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

Sponsor: University of Luebeck

View on ClinicalTrials.gov

Summary

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.

Official title: Augmented Reality Aided Remote Access and tecHnical suppOrt for compLex ablatiOn Procedures

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-08

Completion Date

2028-02

Last Updated

2026-08-20

Healthy Volunteers

No

Interventions

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.

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.

Locations (1)

University Hospital Schleswig-Holstein

Lübeck, Germany