Atrial Fibrillation (AF)HOLO-RemoteNCT07777042
Augmented Reality Aided Remote Access and Technical Support for Complex Ablation Procedures
A study testing HoloLens supported catheter ablation and On-site supported catheter ablation in people with Atrial Fibrillation (AF), run by University of Luebeck at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- HoloLens supported catheter ablation and On-site supported catheter ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age ≥ 18 years
- Indication for 3D electroanatomical mapping-based catheter ablation for the treatment of AF
- Signed written informed consent
Who cannot join
- Patient is unable or unwilling to provide informed consent
- Patient is included in another randomised clinical trial
- Inability to comply with the study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
University Hospital Schleswig-Holstein
Lübeck, 23538
Mirco Küchler, +49 451 500 44542, CTU.EP.LUEBECK@uksh.de
About this study
Official title: Augmented Reality Aided Remote Access and tecHnical suppOrt for compLex ablatiOn Procedures
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.
Read the detailed description
Prospective, randomized, controlled, monocentric, pilot study to evaluate the feasibility and safety of remote access and technical support using an augmented reality system (Microsoft HoloLens headset) in association with the EnSite™ Connected Care solution (EnSite™ Connect Remote Support, Abbott and Medinbox system, Medinbox) as compared to the on-site support for three-dimensional (3D) electroanatomical mapping-based electrophysiological (EP) procedures. Moreover, the study will evaluate the feasibility of an artificial intelligence (AI)-based algorithm integrated within the Medinbox Link system (Medinbox) to analyse video and audio recordings obtained during the procedure, with the aim of automatically generating procedural reports and identifying protocol deviations from the standard of care.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- HoloLens supported catheter ablation, On-site supported catheter ablation
- Keywords
- Atrial fibrillation, Remote access and technical support, Augmented reality, 3D electroanatomical mapping, Catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoloLens supported catheter ablationProcedure or surgery
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 ablationProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: On-site supported catheter ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of the catheter ablation procedure.
Secondary outcomes (15)
Number of participants with periprocedural adverse events
Periprocedural adverse events occurring during the catheter ablation procedure and throughout the index hospitalization will be recorded.
Measured: Periprocedural (from initiation of the catheter ablation procedure until hospital discharge)
Procedural time
Procedural time
Measured: At the end of catheter ablation procedure
Fluoroscopy time
Total fluoroscopy time (minutes) recorded during the catheter ablation procedure.
Measured: 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)
Procedural success will be assessed as successful completion of the intended catheter ablation procedure. A minimum procedural endpoint is successful pulmonary vein isolation (PVI), confirmed by entrance block in all pulmonary veins. Additional ablations may be performed at the operator's discretion based on the patient's clinical characteristics and the planned treatment strategy. When additional ablations are planned or performed, procedural success also requires successful completion of these additional lesion sets according to the predefined procedural objectives.
Measured: End of the catheter ablation procedure
Number of participants requiring conversion from remote technical support to on-site technical support
The number of participants in whom the planned remote technical support could not be maintained and conversion to conventional on-site technical support was required because of technical or procedural reasons (only for interventional group)
Measured: End of the catheter ablation procedure
Technical issues
Technical issues with the remote support system and technical issues with the augmented reality system
Measured: At the end of catheter ablation procedure
Estimated carbon dioxide emissions associated with technical support
Estimated carbon dioxide (CO₂) emissions (kg CO₂ equivalent) associated with travel of field technical engineers to and from the participating study site. Emissions will be calculated from the recorded driving distance using a predefined standardized emission factor. In the remote support group, CO₂ emissions will be calculated based on the estimated distance the field technical engineers would drive if they would have to be on site.
Measured: End of the catheter ablation procedure
Operator satisfaction with the procedural workflow assessed using 10-point numeric rating scales
Operator satisfaction with the procedural workflow will be assessed immediately after completion of the catheter ablation procedure using a 10-point numeric rating scale (NRS), where 0 indicates "not satisfied at all" and 10 indicates "completely satisfied."
Measured: End of the catheter ablation procedure
Successful development of an artificial intelligence algorithm for analysis of recorded catheter ablation procedures to assess predefined procedural quality criteria
Feasibility will be assessed by whether the recorded procedural data from the intervention group are sufficient to develop an artificial intelligence (AI)-based algorithm capable of analyzing predefined procedural quality criteria . The outcome will be reported as successful or unsuccessful algorithm development according to predefined technical performance criteria.
Measured: By completion of the AI algorithm development phase, up to 3 months after completion of data collection
Radiation dose
Total radiation exposure recorded during the catheter ablation procedure, reported as dose area product (DAP, Gy·cm²).
Measured: End of the catheter ablation procedure
Number of participants requiring conversion from HoloLens-assisted remote support to conventional remote support
The number of participants in the intervention group in whom HoloLens-assisted remote technical support could not be maintained and support was continued using conventional remote communication without the Microsoft HoloLens headset because of technical or procedural reasons.
Measured: End of the catheter ablation procedure
Driving time of field technical engineers
Driving time (minutes) required for field technical engineers to travel to and from the participating study site. For participants assigned to the remote support group, driving time will be estimated based on the hypothetical travel time that field technical engineers would have required had conventional on-site technical support been provided.
Measured: End of the catheter ablation procedure
Driving distance of field technical engineers
Driving distance (kilometers) traveled by field technical engineers to and from the participating study site. For participants assigned to the remote support group, driving distance will be estimated based on the hypothetical distance that field technical engineers would have traveled had conventional on-site technical support been provided.
Measured: End of the catheter ablation procedure
Field technical engineer satisfaction with the procedural workflow assessed using 10-point numeric rating scales
Field technical engineer satisfaction with the procedural workflow will be assessed immediately after completion of the catheter ablation procedure using a 10-point numeric rating scale (NRS), where 0 indicates "not satisfied at all" and 10 indicates "completely satisfied."
Measured: End of the catheter ablation procedure
Successful development of an artificial intelligence algorithm for analysis of recorded catheter ablation procedures to generate automated procedural reports
Feasibility will be assessed by whether the recorded procedural data from the intervention group are sufficient to develop an artificial intelligence (AI)-based algorithm capable of generating automated procedural reports. The outcome will be reported as successful or unsuccessful algorithm development according to predefined technical performance criteria.
Measured: By completion of the AI algorithm development phase, up to 3 moths after completion of data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients enrolled in the study and randomized in a 1:1 fashion.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roland Richard Tilz, MD, University of Luebeck
- Investigators
- Roland R Tilz, M.D., Principal investigator, University of Lübeck, Department of RhythmologySorin S Popescu, M.D., Principal investigator, University of Lübeck, Department of Rhythmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777042
- Sponsor's protocol ID
- 2025-221
- Acronym
- HOLO-Remote
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Reality Aided Remote Access and tecHnical suppOrt for compLex ablatiOn Procedures
- ClinicalTrials.gov ID
- NCT07777042
- Acronym / sponsor ID
- HOLO-Remote / 2025-221
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Atrial fibrillation, Remote access and technical support, Augmented reality, 3D electroanatomical mapping, Catheter ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prospective, randomized, controlled, monocentric, pilot study to evaluate the feasibility and safety of remote access and technical support using an augmented reality system (Microsoft HoloLens headset) in association with the EnSite™ Connected Care solution (EnSite™ Connect Remote Support, Abbott and Medinbox system, Medinbox) as compared to the on-site support for three-dimensional (3D) electroanatomical mapping-based electrophysiological (EP) procedures. Moreover, the study will evaluate the feasibility of an artificial intelligence (AI)-based algorithm integrated within the Medinbox Link system (Medinbox) to analyse video and audio recordings obtained during the procedure, with the aim of automatically generating procedural reports and identifying protocol deviations from the standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients enrolled in the study and randomized in a 1:1 fashion.
| Arm | Type | Receives |
|---|---|---|
| HoloLens Group | Experimental | Procedure: HoloLens supported catheter ablationPatients 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). |
| On-site Group | Active comparator | Procedure: On-site supported catheter ablationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients age ≥ 18 years
- Indication for 3D electroanatomical mapping-based catheter ablation for the treatment of AF
- Signed written informed consent
Key exclusion criteria (3 listed)
- Patient is unable or unwilling to provide informed consent
- Patient is included in another randomised clinical trial
- Inability to comply with the study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HoloLens supported catheter ablationPatients 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 or surgery | HoloLens Group |
| On-site supported catheter ablationPatients 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 or surgery | On-site Group |
Primary outcome
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.
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.
15 secondary outcomes
Number of participants with periprocedural adverse events
Time frame: Periprocedural (from initiation of the catheter ablation procedure until hospital discharge)
Procedural time
Time frame: At the end of catheter ablation procedure
Fluoroscopy time
Time frame: 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)
Time frame: End of the catheter ablation procedure
Number of participants requiring conversion from remote technical support to on-site technical support
Time frame: End of the catheter ablation procedure
Technical issues
Time frame: At the end of catheter ablation procedure
Estimated carbon dioxide emissions associated with technical support
Time frame: End of the catheter ablation procedure
Operator satisfaction with the procedural workflow assessed using 10-point numeric rating scales
Time frame: End of the catheter ablation procedure
Successful development of an artificial intelligence algorithm for analysis of recorded catheter ablation procedures to assess predefined procedural quality criteria
Time frame: By completion of the AI algorithm development phase, up to 3 months after completion of data collection
Radiation dose
Time frame: End of the catheter ablation procedure
Number of participants requiring conversion from HoloLens-assisted remote support to conventional remote support
Time frame: End of the catheter ablation procedure
Driving time of field technical engineers
Time frame: End of the catheter ablation procedure
Driving distance of field technical engineers
Time frame: End of the catheter ablation procedure
Field technical engineer satisfaction with the procedural workflow assessed using 10-point numeric rating scales
Time frame: End of the catheter ablation procedure
Successful development of an artificial intelligence algorithm for analysis of recorded catheter ablation procedures to generate automated procedural reports
Time frame: By completion of the AI algorithm development phase, up to 3 moths after completion of data collection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roland R Tilz, M.D. principal investigator
University of Lübeck, Department of Rhythmology
Sorin S Popescu, M.D. principal investigator
University of Lübeck, Department of Rhythmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HoloLens supported catheter ablation and On-site supported catheter ablation in people with Atrial Fibrillation (AF), run by University of Luebeck at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roland R Tilz, M.D. (+49 451 500 44580, tilz6@hotmail.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.