An Evaluation of the Safety and Performance of the CathVision ECGenius® System.
NCT ID: NCT05301803
Last Updated: 2024-09-05
Study Results
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View full resultsBasic Information
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COMPLETED
27 participants
OBSERVATIONAL
2022-03-29
2023-12-31
Brief Summary
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Detailed Description
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Patients undergoing assessment and ablation of cardiac arrhythmias during an electrophysiology (EP) procedure, and who meet all inclusion criteria will be enrolled in the study and undergo the EP procedure. Intracardiac signals will be passively recorded using the CathVision ECGenius® System in parallel with a commercial EP recording system and later compared and evaluated. The investigational device will not be used for direct clinical care decisions or therapy. The EP procedure will be guided by the study site Standards Of Care.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Electrophysiology procedure
Electrophysiology testing and cardiac ablation of arrhythmia
Eligibility Criteria
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Inclusion Criteria
* At least 18 years of age.
* Able and willing to provide informed consent or obtain consent from a legally authorized representative (LAR).
Exclusion Criteria
* Patient is a prisoner or under incarceration
* Patients who in the opinion of the physician are not candidates for this study.
18 Years
ALL
No
Sponsors
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Medicept Inc.
INDUSTRY
CathVision ApS
INDUSTRY
Responsible Party
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Principal Investigators
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Nathaniel C Thompson, MD PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Vermont Medical Center
Locations
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The University of vermont
Burlington, Vermont, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CP-00003-A
Identifier Type: -
Identifier Source: org_study_id
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