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

NCT07777042 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-20

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation (AF)

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.

Sponsors & Collaborators

  • University of Luebeck

    lead OTHER

Principal Investigators

  • Roland R Tilz, M.D. · University of Lübeck, Department of Rhythmology

  • Sorin S Popescu, M.D. · University of Lübeck, Department of Rhythmology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-02-29
Completion
2028-02-29

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07777042 on ClinicalTrials.gov