NCT07777042

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Aug 2026Feb 2028

Study Start

First participant enrolled

August 1, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 20, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

August 20, 2026

Status Verified

August 1, 2026

Enrollment Period

1.5 years

First QC Date

August 5, 2026

Last Update Submit

August 16, 2026

Conditions

Atrial Fibrillation (AF)

Keywords

Atrial fibrillationRemote access and technical supportAugmented reality3D electroanatomical mappingCatheter ablation

Outcome Measures

Primary Outcomes (1)

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

    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.

Secondary Outcomes (15)

  • Number of participants with periprocedural adverse events

    Periprocedural (from initiation of the catheter ablation procedure until hospital discharge)

  • Procedural time

    At the end of catheter ablation procedure

  • Fluoroscopy time

    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)

    End of the catheter ablation procedure

  • Number of participants requiring conversion from remote technical support to on-site technical support

    End of the catheter ablation procedure

  • +10 more secondary outcomes

Study Arms (2)

HoloLens Group

EXPERIMENTAL

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).

Procedure: HoloLens supported catheter ablation

On-site Group

ACTIVE COMPARATOR

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.

Procedure: On-site supported catheter ablation

Interventions

HoloLens supported catheter ablationPROCEDURE

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.

HoloLens Group
On-site supported catheter ablationPROCEDURE

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.

On-site Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients age ≥ 18 years
  • Indication for 3D electroanatomical mapping-based catheter ablation for the treatment of AF
  • Signed written informed consent

You may not qualify if:

  • Patient is unable or unwilling to provide informed consent
  • Patient is included in another randomised clinical trial
  • Inability to comply with the study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Schleswig-Holstein

Lübeck, 23538, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Roland R Tilz, M.D.

    University of Lübeck, Department of Rhythmology

    PRINCIPAL INVESTIGATOR

  • Sorin S Popescu, M.D.

    University of Lübeck, Department of Rhythmology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roland R Tilz, M.D.

CONTACT

+49 451 500 44580tilz6@hotmail.de

Sorin S Popescu, M.D.

CONTACT

+49 451 500 77072sorin.popescu29@yahoo.ro

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients enrolled in the study and randomized in a 1:1 fashion.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 20, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

August 20, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.

Locations

DE(1)