Automated Assessment of PVI Using a Novel EP Recording System
NCT ID: NCT05043883
Last Updated: 2024-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
101 participants
INTERVENTIONAL
2021-09-15
2022-06-22
Brief Summary
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Detailed Description
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The primary objective is to validate the PVI Analyzer software with a novel EP recording system (CathVision Cube® System) for assisting assessment of isolation status following PVI ablation.
The secondary objective is to determine the feasibility of "real-time" assessment of PVI analysis and rhythm dependent performance using the PVI Analyzer and CathVision Cube® System.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Group
Index EP Procedure: Ablation of atrial fibrillation
CathVision Cube® system
Intracardiac signals will be passively recorded using the investigational CathVision Cube® System in parallel with the commercial (bearing CE mark) EP recording systems LabSystem Pro, Boston Scientific EP, or EP-Tracer, Schwarzer Cardiotek. The investigational device will not be used for direct clinical care decisions or therapy. The validation of the PVI Analyzer will be performed offline and retrospectively.
Interventions
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CathVision Cube® system
Intracardiac signals will be passively recorded using the investigational CathVision Cube® System in parallel with the commercial (bearing CE mark) EP recording systems LabSystem Pro, Boston Scientific EP, or EP-Tracer, Schwarzer Cardiotek. The investigational device will not be used for direct clinical care decisions or therapy. The validation of the PVI Analyzer will be performed offline and retrospectively.
Eligibility Criteria
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Inclusion Criteria
2. Male or non-pregnant female aged ≥21 years.
3. Able and willing to provide written informed consent prior to any clinical investigation related procedure
Exclusion Criteria
2. Current participation in another investigational drug or device study that interferes with this Study.
3. Subjects who, in the opinion of the investigator, are not candidates for this Study.
4. Patients who have had a prior ablation procedure
5. 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.
6. Life expectancy less than 12 month
7. Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.
21 Years
ALL
No
Sponsors
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AKRN Scientific Consulting, S.L.
INDUSTRY
CathVision ApS
INDUSTRY
Responsible Party
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Principal Investigators
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Mattias Duytschaever, Prof. MD PhD
Role: PRINCIPAL_INVESTIGATOR
AZ Sint-Jan Hospital, Ruddershove 10 8000 Brugge, Belgium
Locations
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AZ Sint-Jan Hospital
Bruges, , Belgium
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Ghent University Hospital
Ghent, , Belgium
Clinique Pasteur Toulouse,
Toulouse, , France
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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CPVI-002
Identifier Type: -
Identifier Source: org_study_id
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