Augmented Reality Aided Remote Access and Technical Support for Complex Ablation Procedures (HOLO-Remote)
2026년 8월 16일 업데이트: Roland Richard Tilz, MD, University of Luebeck
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.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
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.
연구 유형
중재적
등록 (추정된)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Roland R Tilz, M.D.
- 전화번호: +49 451 500 44580
- 이메일: tilz6@hotmail.de
연구 연락처 백업
- 이름: Sorin S Popescu, M.D.
- 전화번호: +49 451 500 77072
- 이메일: sorin.popescu29@yahoo.ro
연구 장소
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Lübeck, 독일, 23538
- University Hospital Schleswig-Holstein
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연락하다:
- Mirco Küchler
- 전화번호: +49 451 500 44542
- 이메일: CTU.EP.LUEBECK@uksh.de
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: HoloLens Group
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).
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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.
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활성 비교기: On-site Group
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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Feasibility: Number of participants in whom remotely supported 3D electroanatomical mapping-based atrial fibrillation ablation is successfully completed
기간: At the end of the catheter ablation procedure.
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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.
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At the end of the catheter ablation procedure.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of participants with periprocedural adverse events
기간: Periprocedural (from initiation of the catheter ablation procedure until hospital discharge)
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Periprocedural adverse events occurring during the catheter ablation procedure and throughout the index hospitalization will be recorded.
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Periprocedural (from initiation of the catheter ablation procedure until hospital discharge)
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Procedural time
기간: At the end of catheter ablation procedure
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Procedural time
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At the end of catheter ablation procedure
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Fluoroscopy time
기간: End of the catheter ablation procedure
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Total fluoroscopy time (minutes) recorded during the catheter ablation procedure.
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End of the catheter ablation procedure
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Number of participants with successful completion of the intended catheter ablation procedure (the minimum procedural endpoint is successful pulmonary vein isolation)
기간: End of the catheter ablation procedure
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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.
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End of the catheter ablation procedure
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Number of participants requiring conversion from remote technical support to on-site technical support
기간: End of the catheter ablation procedure
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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)
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End of the catheter ablation procedure
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Technical issues
기간: At the end of catheter ablation procedure
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Technical issues with the remote support system and technical issues with the augmented reality system
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At the end of catheter ablation procedure
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Estimated carbon dioxide emissions associated with technical support
기간: End of the catheter ablation procedure
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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.
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End of the catheter ablation procedure
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Operator satisfaction with the procedural workflow assessed using 10-point numeric rating scales
기간: End of the catheter ablation procedure
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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."
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End of the catheter ablation procedure
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Successful development of an artificial intelligence algorithm for analysis of recorded catheter ablation procedures to assess predefined procedural quality criteria
기간: By completion of the AI algorithm development phase, up to 3 months after completion of data collection
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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.
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By completion of the AI algorithm development phase, up to 3 months after completion of data collection
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Radiation dose
기간: End of the catheter ablation procedure
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Total radiation exposure recorded during the catheter ablation procedure, reported as dose area product (DAP, Gy·cm²).
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End of the catheter ablation procedure
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Number of participants requiring conversion from HoloLens-assisted remote support to conventional remote support
기간: End of the catheter ablation procedure
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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.
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End of the catheter ablation procedure
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Driving time of field technical engineers
기간: End of the catheter ablation procedure
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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.
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End of the catheter ablation procedure
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Driving distance of field technical engineers
기간: End of the catheter ablation procedure
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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.
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End of the catheter ablation procedure
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Field technical engineer satisfaction with the procedural workflow assessed using 10-point numeric rating scales
기간: End of the catheter ablation procedure
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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."
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End of the catheter ablation procedure
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Successful development of an artificial intelligence algorithm for analysis of recorded catheter ablation procedures to generate automated procedural reports
기간: By completion of the AI algorithm development phase, up to 3 moths after completion of data collection
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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.
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By completion of the AI algorithm development phase, up to 3 moths after completion of data collection
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Roland R Tilz, M.D., University of Lübeck, Department of Rhythmology
- 수석 연구원: Sorin S Popescu, M.D., University of Lübeck, Department of Rhythmology
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2028년 2월 1일
연구 완료 (추정된)
2028년 2월 1일
연구 등록 날짜
최초 제출
2026년 8월 5일
QC 기준을 충족하는 최초 제출
2026년 8월 16일
처음 게시됨 (실제)
2026년 8월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 16일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2025-221
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .