The Automated Calculation of AF Cycle Length and Complexity Using a Novel EP Recording System
NCT ID: NCT05477602
Last Updated: 2026-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
21 participants
OBSERVATIONAL
2023-01-16
2024-12-31
Brief Summary
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Detailed Description
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Subjects with persistent AF who are indicated to undergo a routine-practice RF ablation may be enrolled in the Study. Intracardiac signals will be passively recorded using the investigational CathVision ECGenius® System in parallel with a commercial (CE Approved) EP recording system. The investigational device will not be used for direct clinical care decisions or therapy.
The validation of the Signal Complexity Visualization Algorithm will be performed offline and retrospectively.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Cardiac Ablation for the treatment of persistent Atrial Fibrillation
Patients undergoing cardiac ablation for the treatment of persistent atrial fibrillation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or non-pregnant female aged ≥ 21 years.
* Able and willing to provide written informed consent prior to any clinical investigation related procedure.
Exclusion Criteria
* Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
* Life expectancy less than 12 month, in the opinion of the Investigator.
* Subjects who, in the opinion of the investigator, are not candidates for this study.
* Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.
21 Years
85 Years
ALL
No
Sponsors
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CathVision ApS
INDUSTRY
Responsible Party
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Locations
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OLV Aalst
Aalst, , Belgium
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CVAR-00002-A
Identifier Type: -
Identifier Source: org_study_id
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