Automated Assessment of PVI Using a Novel EP Recording System

Study Overview
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Brief Summary
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A prospective, multi-center study with the CathVision Cube® system and the PVI Analyzer software in radiofrequency (RF), cryo-balloon (CB), and Pulse Field Ablation (PFA) procedures.

Detailed Description
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Subjects with paroxysmal or persistent atrial fibrillation (AF) who are indicated to undergo first pulmonary vein isolation (PVI) procedure and meet all eligibility criteria will be enrolled in the Study. Intracardiac signals will be passively recorded using the investigational CathVision Cube® System in parallel with the conventional (CE marked) EP recording system. The investigational device will not be used for direct clinical care decisions or therapy. The validation of the automated algorithm for PVI will be performed offline 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.

Official Title
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Automated Assessment of Pulmonary Vein Isolation (PVI) Using a Novel EP Recording System (CathVision Cube® System)

Conditions
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Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

Intervention / Treatment
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* Device: CathVision Cube® system


Participation Criteria
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Eligibility Criteria
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Eligible subjects will meet all of the following inclusion criteria: Subjects undergoing first-time pulmonary vein isolation indicated by investigator for the treatment of atrial fibrillation Male or non-pregnant female aged ≥21 years. Able and willing to provide written informed consent prior to any clinical investigation related procedure Eligible subjects will not meet any of the following exclusion criteria: Pregnant or nursing subjects. Current participation in another investigational drug or device study that interferes with this Study. Subjects who, in the opinion of the investigator, are not candidates for this Study. Patients who have had a prior ablation procedure 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 Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Group<br>Index EP Procedure: Ablation of atrial fibrillation | Device: CathVision Cube® system<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary performance objective is to validate the PVI Analyzer software with a novel EP recording system (CathVision Cube® System) for assessment of isolation status following PVI ablation. | Sensitivity and specificity of PVI Analyzer classification of isolation status following PVI ablation using data from the investigational CathVision Cube System. Specificity is defined as the ratio of correct negative (non-isolated) predictions among data points from non-isolated veins. Sensitivity is defined as the ratio of correct positive (isolated) data points from isolated veins. Classification is performed using recorded data before and after the isolation of each available pulmonary vein independently. | From EP procedure until study completion at discharge; an average of 24 hours. | 
| The safety endpoint of the Study will evaluate the adverse events and/or device malfunctions reported with the use of the CathVision Cube® System. | Evaluation of adverse events and/or device malfunctions reported with the use of the CathVision Cube® System during the procedure until discharge. | From EP procedure until study completion at discharge; an average of 24 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of automated PVI Analyzer classification of PV isolation in SR during Cryo-balloon ablation | Sensitivity and specificity of PVI Analyzer classification of isolation status within the Cryo-balloon ablation subgroup. Classification, sensitivity and specificity are defined in the same way as for the primary endpoint. | From EP procedure until study completion at discharge; an average of 24 hours. | 
| Accuracy of automated PVI Analyzer classification of PV isolation in SR during RF ablation | Sensitivity and specificity of PVI Analyzer classification of isolation status within the RF ablation subgroup. Classification, sensitivity and specificity are defined in the same way as for the primary endpoint. | From EP procedure until study completion at discharge; an average of 24 hours. | 
| Assessment of automated PVI Analyzer classification of PV isolation in SR after PFA | Sensitivity and specificity of PVI Analyzer classification of isolation status within the PFA ablation subgroup. Classification, sensitivity and specificity are defined in the same way as for the primary endpoint. | From EP procedure until study completion at discharge; an average of 24 hours. | 
| Feasibility of real-time assessment of isolation | Retest accuracy of PVI Analyzer classification of isolation status at different timepoints before, during and after ablation. The accuracy is defined as the agreement of re-classification of pairs of non-overlapping samples before, during and after ablation. | From EP procedure until study completion at discharge; an average of 24 hours. | 
| Automated PVI Analyzer classification of PV isolation in NSR | Sensitivity and specificity of PVI Analyzer classification of isolation status within the subgroup of data recorded in non-sinus rhythm. Non-sinus rhythm is defined as any rhythm not regarded as sinus rhythm, including atrial fibrillation, typical- and atypical atrial flutter. Classification, sensitivity and specificity are measured in the same way as for primary endpoint. | From EP procedure until study completion at discharge; an average of 24 hours. | 
| PVI Analyzer classification accuracy at the time of expert-defined isolation | Sensitivity of PVI Analyzer analysis to identify expert-defined isolation during PVI ablation. | From EP procedure until study completion at discharge; an average of 24 hours. | 
| Comparison of device performance with conventional system | Specificity and sensitivity of PVI Analyzer analysis to identify isolation using data from the conventional system. | From EP procedure until study completion at discharge; an average of 24 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, pulmonary vein isolation, radiofrequency, cryo balloon, ablation, software, pulse field ablation