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

NCT07777042 · tracked via the Priya Life Science Germany tracker

Sponsor

University of Luebeck

Phase

Not applicable

Started

2026-08

Last updated

2026-08-20

Condition(s) studied

Atrial Fibrillation (AF)

Investigational drug(s) / intervention(s)

HoloLens supported catheter ablationOn-site supported catheter ablation

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.

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.

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Feasibility: Number of participants in whom remotely supported 3D electroanatomical mapping-based atrial fibrillation ablation is successfully completed — 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.

Trial sites (1)

Facility	City	Region	Status
University Hospital Schleswig-Holstein	Lübeck	Germany

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07777042 on ClinicalTrials.gov ↗ ← All trials in Germany