Feasibility and Safety of the Augmented Reality Guidance Software TAVIPILOT Software During Transcatheter Aortic Valve Replacement (TAVR/TAVI)
NCT ID: NCT07100340
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
10 participants
INTERVENTIONAL
2025-09-15
2026-03-15
Brief Summary
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The objective is to assess the feasibility and safety of the TAVIPILOT Software augmented reality guidance software during TAVI procedures, aiming to improve valve positioning precision and, implicitly and to reduce implantation depth variations.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TAVR procedure with TAVIPILOT Software (investigational medical device)
Use of the TAVIPILOT Software during the procedure
TAVR using a guidance software
TAVR procedure with TAVIPILOT augmented reality guidance software operating during the procedure, enabling clinicians to assess the live analysis and recommendations provided by the software.
Interventions
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TAVR using a guidance software
TAVR procedure with TAVIPILOT augmented reality guidance software operating during the procedure, enabling clinicians to assess the live analysis and recommendations provided by the software.
Eligibility Criteria
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Inclusion Criteria
2. Indicated for transfemoral TAVR for severe aortic stenosis
65 Years
ALL
No
Sponsors
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Caranx Medical
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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55003
Identifier Type: -
Identifier Source: org_study_id
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