Single Center Pilot Study Using the ECGenius System to Collect Electrogram Data to Test an Ablation Impact Algorithm
NCT ID: NCT05458648
Last Updated: 2025-12-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
37 participants
OBSERVATIONAL
2022-07-28
2024-12-31
Brief Summary
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Detailed Description
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Subjects with persistent atrial fibrillation who are indicated to undergo an RF ablation to treat persistent AF may be enrolled in the Study.
Intracardiac signals will be passively recorded using the investigational ECGenius® System in parallel with the commercial (FDA Approved) EP Workmate, Abbott Inc. EP recording system. The investigational device will not be used for direct clinical care decisions or therapy.
The CathVision ECGenius system allows physicians and users to record intracardiac electrograms during human electrophysiological studies including treatments for atrial fibrillation and atrial tachycardias. Improvements to the first-generation system are in development and include software features and algorithms for further analysis and description of signals to improve the clinical utility of the recorded signals. These new algorithms and software features require leveraging clinical use data as part of the development and iteration process.
This study will allow the evaluation of algorithms for advanced signal analysis in a low-risk clinical setting by recording raw electrocardiograms during standard of care cardiac mapping and ablation treatments for tachyarrhythmias, specifically atrial tachycardias and atrial fibrillation. The data will be recorded by a conventional market-approved EP recording system and on a parallel investigational CathVision ECGenius system for subsequent offline prototype analysis. Information from the investigational system and algorithms will not be available to the physician during the treatment and will have no diagnostic or therapeutic impact on the clinical case.
The validation of the automated algorithm will be performed offline.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Persistent AF Arm
Patients undergoing cardiac ablation for the treatment of persistent atrial fibrillation
Cardiac Ablation for the treatment of persistent Atrial Fibrillation
Patients participating in the study will undergo a cardiac ablation for the treatment of persistent atrial fibrillation.
Interventions
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Cardiac Ablation for the treatment of persistent Atrial Fibrillation
Patients participating in the study will undergo a cardiac ablation for the treatment of persistent atrial fibrillation.
Eligibility Criteria
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Inclusion Criteria
2. Male or female ≥ 21 years of age.
3. Able and willing to provide written informed consent prior to any clinical investigation related procedure.
Exclusion Criteria
2. Patients who, in the opinion of the investigator, are not candidates for this study.
3. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the patient'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.
4. Life expectancy less than 12 month, in the opinion of the Investigator.
5. Patients who are considered part of any vulnerable population.
6. Patient is a prisoner.
21 Years
85 Years
ALL
No
Sponsors
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CathVision ApS
INDUSTRY
Responsible Party
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Principal Investigators
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Larry Jacob, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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CVAR-00001-A
Identifier Type: -
Identifier Source: org_study_id