Trial Outcomes & Findings for Automated Assessment of PVI Using a Novel EP Recording System (NCT NCT05043883)
NCT ID: NCT05043883
Last Updated: 2024-08-09
Results Overview
The primary outcome is to evaluate the sensitivity and specificity of the PVI Analyzer in the classification of the isolation status of veins, following the medical procedure known as pulmonary vein isolation (PVI). The information used for this has been obtained from the investigational CathVision Cube System. The PVI Analyzer determines whether the veins are isolated or not after pulmonary vein ablation. The proportion of correct negative (non-isolated) predictions among non-isolated vein data points and the proportion of correct positive (isolated) data points from isolated veins, provide the sensitivity and specificity data, respectively.
COMPLETED
NA
101 participants
From EP procedure until study completion at discharge; an average of 24 hours.
2024-08-09
Participant Flow
The enrollment took place between September 15, 2021 and June 22, 2022 at four sites (hospitals) located in Bruges, Brussels, Ghent and Toulouse. At these hospitals, participants were assessed for eligibility to participate in the clinical investigation, and those who met the eligibility criteria, voluntarily gave their informed consent. Those who were successfully enrolled were monitored until their hospital discharge, and no further follow-up was deemed necessary.
Three of the subjects were considered screening failures since not all eligibility criteria were met, and the subjects were excluded from the study. Out of the 101 subjects enrolled, 4 subjects were excluded from the Per-Protocol Treatment analysis, as minimum required measurements could not be taken. Therefore, the final PPT population for analysis was 97 subjects.
Participant milestones
| Measure |
Index EP Procedure: Ablation of Atrial Fibrillation
This is a single arm study that is assigned to subjects undergoing first-time pulmonary vein isolation indicated by investigator for the treatment of atrial fibrillation. Subjects were distributed in two different procedures (RF and cryo-balloon) according to medical decision and standard of care practice at the study sites. At a later stage, a protocol amendment planned an additional enrolment undergoing the standard of care PFA procedure
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.
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|---|---|
|
Overall Study
STARTED
|
101
|
|
Overall Study
COMPLETED
|
97
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Index EP Procedure: Ablation of Atrial Fibrillation
This is a single arm study that is assigned to subjects undergoing first-time pulmonary vein isolation indicated by investigator for the treatment of atrial fibrillation. Subjects were distributed in two different procedures (RF and cryo-balloon) according to medical decision and standard of care practice at the study sites. At a later stage, a protocol amendment planned an additional enrolment undergoing the standard of care PFA procedure
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.
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|---|---|
|
Overall Study
Minimum required measurements could not be taken
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Index EP Procedure: Ablation of Atrial Fibrillation
n=101 Participants
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.
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|---|---|
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Age, Continuous
|
62.76 years
STANDARD_DEVIATION 12.31 • n=101 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=101 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=101 Participants
|
|
Height [cm]
|
174.23 cm
STANDARD_DEVIATION 9.83 • n=101 Participants
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|
Weight [kg]
|
82.04 kg
STANDARD_DEVIATION 17.86 • n=101 Participants
|
|
Systolic Blood Pressure [mmHg]
|
137.39 mmHg
STANDARD_DEVIATION 20.04 • n=101 Participants
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|
Diastolic Blood Pressure [mmHg]
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79.44 mmHg
STANDARD_DEVIATION 12.10 • n=101 Participants
|
|
Heart Rate [BPM]
|
72.69 BPM
STANDARD_DEVIATION 22.40 • n=101 Participants
|
|
Respiratory Rate [breaths/min]
|
14.88 breaths/min
STANDARD_DEVIATION 5.17 • n=101 Participants
|
|
Body Temperature [°C]
|
36.28 ºC
STANDARD_DEVIATION 0.42 • n=101 Participants
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PRIMARY outcome
Timeframe: From EP procedure until study completion at discharge; an average of 24 hours.Population: The performance assessment was done in the PPT population, with a total of 85 subjects. Subjects undergoing PFA were excluded from this analysis despite being included in the PPT population, since the primary endpoint was specific to RF and Cryo procedures only. Up to 248 EGMs were recorded at 'T-baseline' (prior to isolation) and labeled as ground-truth negative (non-isolated); and 250 EGMs were recorded at 'T-final' (after isolation) and labeled as ground-truth positive (isolated).
The primary outcome is to evaluate the sensitivity and specificity of the PVI Analyzer in the classification of the isolation status of veins, following the medical procedure known as pulmonary vein isolation (PVI). The information used for this has been obtained from the investigational CathVision Cube System. The PVI Analyzer determines whether the veins are isolated or not after pulmonary vein ablation. The proportion of correct negative (non-isolated) predictions among non-isolated vein data points and the proportion of correct positive (isolated) data points from isolated veins, provide the sensitivity and specificity data, respectively.
Outcome measures
| Measure |
Single Group
n=498 Electrogram (EGM)
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.
|
Cryoballoon Procedure
Index EP Procedure: Ablation of atrial fibrillation according to Cryo-ballon Procedure: cryo-balloon ablates the tissue through freezing.
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.
|
Pulsed Field Ablation (PFA) Procedure
PFA delivers short high-voltage pulses that ablates through irreversible electroporation.
The data obtained from pulsed field ablation (PFA) analysis could not be assessed for this secondary endpoint as it was found to be incompatible with the PVI Analyzer algorithm, which requires the PV mapping catheter to have eight or ten electrodes and the PFA catheter has only five.
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|---|---|---|---|
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PVI Analyzer Sensitivity and Specificity, Measured as the Accuracy of Predictions for Non-isolated and Isolated Veins.
Sensitivity
|
216 Electrogram (EGM)
|
—
|
—
|
|
PVI Analyzer Sensitivity and Specificity, Measured as the Accuracy of Predictions for Non-isolated and Isolated Veins.
Specificity
|
215 Electrogram (EGM)
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—
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—
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PRIMARY outcome
Timeframe: From EP procedure until study completion at discharge; an average of 24 hours.Population: All enrolled subjects.
As part of the primary outcome, safety is also evaluated as the number of adverse events and device malfunctions reported by the study team at site, during the use of the CathVision Cube® System from the start of the procedure until discharge. The number of adverse events and device malfunctions is recorded in the site's source documents as well as in the case report form (CRF) and is duly informed to the Sponsor who also keeps the record.
Outcome measures
| Measure |
Single Group
n=101 Participants
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.
|
Cryoballoon Procedure
Index EP Procedure: Ablation of atrial fibrillation according to Cryo-ballon Procedure: cryo-balloon ablates the tissue through freezing.
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.
|
Pulsed Field Ablation (PFA) Procedure
PFA delivers short high-voltage pulses that ablates through irreversible electroporation.
The data obtained from pulsed field ablation (PFA) analysis could not be assessed for this secondary endpoint as it was found to be incompatible with the PVI Analyzer algorithm, which requires the PV mapping catheter to have eight or ten electrodes and the PFA catheter has only five.
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|---|---|---|---|
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PVI Analyzer Safety Profile, Measured as the Number of Adverse Events and/or Device Malfunctions.
Device deficiency incidence
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0 participants
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—
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—
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PVI Analyzer Safety Profile, Measured as the Number of Adverse Events and/or Device Malfunctions.
Mild
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0 participants
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—
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—
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PVI Analyzer Safety Profile, Measured as the Number of Adverse Events and/or Device Malfunctions.
Moderate
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1 participants
|
—
|
—
|
|
PVI Analyzer Safety Profile, Measured as the Number of Adverse Events and/or Device Malfunctions.
Severe
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0 participants
|
—
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—
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|
PVI Analyzer Safety Profile, Measured as the Number of Adverse Events and/or Device Malfunctions.
Device related
|
0 participants
|
—
|
—
|
|
PVI Analyzer Safety Profile, Measured as the Number of Adverse Events and/or Device Malfunctions.
Procedure related
|
1 participants
|
—
|
—
|
|
PVI Analyzer Safety Profile, Measured as the Number of Adverse Events and/or Device Malfunctions.
other
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0 participants
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—
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—
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PVI Analyzer Safety Profile, Measured as the Number of Adverse Events and/or Device Malfunctions.
Serious Adverse Events
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1 participants
|
—
|
—
|
|
PVI Analyzer Safety Profile, Measured as the Number of Adverse Events and/or Device Malfunctions.
Serious adverse device effect (SADE) incidence
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0 participants
|
—
|
—
|
|
PVI Analyzer Safety Profile, Measured as the Number of Adverse Events and/or Device Malfunctions.
Serious unanticipated serious adverse device effect (USADE) incidence
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From EP procedure until study completion at discharge; an average of 24 hours.Population: This secondary outcome assessed the overall classification accuracy of the PVI Analyzer in sinus rhythm (SR) computing the results only in radiofrequency and cryoballoon procedures. Therefore, the dataset used for the analysis is the same as for the primary endpoint (85), but subgrouping the data by the type of procedure.
This outcome assesses the overall classification of pulmonary vein isolation (PVI) in sinus rhythm (SR) based on the type of electrophysiology procedure performed. The classification provides insights into the accuracy of the procedure in achieving SR. The overall classification was evaluated in terms of sensitivity and specificity. To calculate specificity from the total number of EGMS analyzed, all the correct negatives (non-isolated) / Correct negatives + False positives were considered. To calculate sensitivity, all the correct positives (isolated) / Correct positives + False negatives were considered. As the sample size was not adjusted to detect the differences for variables other than the primary endpoint, the p-values obtained from the analyses of secondary outcomes should be viewed as complementary to the primary outcome results. Their primary purpose was to generate hypotheses rather than draw definitive conclusions.
Outcome measures
| Measure |
Single Group
n=258 Electrogram (EGM)
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.
|
Cryoballoon Procedure
n=240 Electrogram (EGM)
Index EP Procedure: Ablation of atrial fibrillation according to Cryo-ballon Procedure: cryo-balloon ablates the tissue through freezing.
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.
|
Pulsed Field Ablation (PFA) Procedure
PFA delivers short high-voltage pulses that ablates through irreversible electroporation.
The data obtained from pulsed field ablation (PFA) analysis could not be assessed for this secondary endpoint as it was found to be incompatible with the PVI Analyzer algorithm, which requires the PV mapping catheter to have eight or ten electrodes and the PFA catheter has only five.
|
|---|---|---|---|
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The Pulmonar Vein Isolation (PVI) Classification in Sinus Rhythm (SR) Considering the Electrophysiology Procedure Type.
Specificty
|
120 Electrogram (EGM)
|
95 Electrogram (EGM)
|
0 Electrogram (EGM)
|
|
The Pulmonar Vein Isolation (PVI) Classification in Sinus Rhythm (SR) Considering the Electrophysiology Procedure Type.
Sensitivity
|
107 Electrogram (EGM)
|
109 Electrogram (EGM)
|
0 Electrogram (EGM)
|
SECONDARY outcome
Timeframe: From EP procedure until study completion at discharge; an average of 24 hours.Population: EGMs with a number of global isolation index values above 6 were selected. For those EGMs, the fourth and last global index returned by the PVI Analyzer were used. This value was compared at different time points of the procedure, to confirm whether there was an ECG agreement or not. The number of EGM with agreement was 475/495, and the number of EGM without agreement was 20/475.
The device's feasibility was evaluated by reassessing its accuracy. It refers to the consistency in the re-classification of pairs of non-overlapping samples throughout the different timepoints of ablation-prior to, during, and following the procedure. For this evaluation, the same EGMs of the primary endpoint were used, including only EGMs from T Baseline and T Final measurements from patients in sinus rhythm. The extraction of non-overlapping samples was selected by considering only those EGMs with a number of global isolation index values above 6. The global isolation index value is an indicator from the PVI analyzer that is used to assess the overall effectiveness of the ablation in isolating specific regions of the heart. The fourth and last global index returned by the PVI Analyzer were used as pairs for analyzing the outcome. The accuracy was calculated as the percentage of EGMs with agreement across timepoints with respect to the total number of EGMs performed.
Outcome measures
| Measure |
Single Group
n=495 Electrogram (EGM)
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.
|
Cryoballoon Procedure
Index EP Procedure: Ablation of atrial fibrillation according to Cryo-ballon Procedure: cryo-balloon ablates the tissue through freezing.
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.
|
Pulsed Field Ablation (PFA) Procedure
PFA delivers short high-voltage pulses that ablates through irreversible electroporation.
The data obtained from pulsed field ablation (PFA) analysis could not be assessed for this secondary endpoint as it was found to be incompatible with the PVI Analyzer algorithm, which requires the PV mapping catheter to have eight or ten electrodes and the PFA catheter has only five.
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|---|---|---|---|
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Feasibility of "Real-time" Assessment of Isolation, Measured by Retesting the Accuracy of the PVI Analyzer Classification of Isolation Status at Different Timepoints Before, During and After Ablation.
|
475 Electrogram (EGM)
|
—
|
—
|
SECONDARY outcome
Timeframe: From EP procedure until study completion at discharge; an average of 24 hours.Population: The performance assessment was done in the Per Protocol (PPT) population, with a total of 85 participants. The PVI isolation classification in non-sinus rhythm (NSR) from EP procedure was focused on the analysis of all EGM in non-sinus rhythm which in this case were 55 in T-baseline and 44 in T-final, a total of 99 ECGs. However, the system rejected 9 ECGs in T-baseline and 3 in T-final, therefore, the ECGs used for this secondary outcome were 46 in T-baseline and 41 in T-final.
The PVI isolation classification in non-sinus rhythm (NSR) from EP procedure was focused on the analysis of all EGM in non-sinus rhythm. The data analysis and processing were similar to those of the primary endpoint, but taking into consideration that subjects shall be in non-sinus rhythm during the duration of the EGM snippet. Apart from this, the processing was the same and the threshold was also defined as 50: values below 50 were classified as baseline, while values at or above 50 were considered as isolated veins.
Outcome measures
| Measure |
Single Group
n=87 Electrogram (EGM)
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.
|
Cryoballoon Procedure
Index EP Procedure: Ablation of atrial fibrillation according to Cryo-ballon Procedure: cryo-balloon ablates the tissue through freezing.
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.
|
Pulsed Field Ablation (PFA) Procedure
PFA delivers short high-voltage pulses that ablates through irreversible electroporation.
The data obtained from pulsed field ablation (PFA) analysis could not be assessed for this secondary endpoint as it was found to be incompatible with the PVI Analyzer algorithm, which requires the PV mapping catheter to have eight or ten electrodes and the PFA catheter has only five.
|
|---|---|---|---|
|
PVI Isolation Classification in Non-sinus Rhythm (NSR) From EP Procedure
Specificity
|
25 Electrogram (EGM)
|
—
|
—
|
|
PVI Isolation Classification in Non-sinus Rhythm (NSR) From EP Procedure
Sensitivity
|
41 Electrogram (EGM)
|
—
|
—
|
SECONDARY outcome
Timeframe: From EP procedure until study completion at discharge; an average of 24 hours.Population: In many cases, the actual isolation time was not directly observable, and the investigator was only asked to annotate T PVI if it was observed. During RF procedures, T PVI can be difficult to observe and during cryo-balloon application, freeze noise from the cryoballoon can make identification of T PVI difficult. The annotation the EGMs at the T PVI was not always possible and only 116 valid EGMs at T PVI were collected. During processing, 17 EGMs were rejected by the PVI Analyzer.
This secondary endpoint aimed to determine the sensitivity of the PVI Analyzer at the time of isolation, which requires the EGMs at the T PVI. The T PVI EGMs were extracted by taking EGM snippets of 4 seconds around the T PVI event. All of those EGMs were expected to be from isolated veins (ground-truth is isolated). Then, they were processed by the PVI Analyzer, and the last valid global isolation index output was used for endpoint assessment.
Outcome measures
| Measure |
Single Group
n=99 Electrogram (EGM)
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.
|
Cryoballoon Procedure
Index EP Procedure: Ablation of atrial fibrillation according to Cryo-ballon Procedure: cryo-balloon ablates the tissue through freezing.
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.
|
Pulsed Field Ablation (PFA) Procedure
PFA delivers short high-voltage pulses that ablates through irreversible electroporation.
The data obtained from pulsed field ablation (PFA) analysis could not be assessed for this secondary endpoint as it was found to be incompatible with the PVI Analyzer algorithm, which requires the PV mapping catheter to have eight or ten electrodes and the PFA catheter has only five.
|
|---|---|---|---|
|
Accuracy of PVI Analyzer Classification at the Time of Expert-defined Isolation
|
86 Electrogram (EGM)
|
—
|
—
|
SECONDARY outcome
Timeframe: From EP procedure until study completion at discharge; an average of 24 hours.Population: It was not possible to extract all EGM snippets from the conventional systems, as all data from Toulouse was not available. Due to technical reasons and time constraints, only the first 12 patients from Ghent were included in the analysis.
The conventional EP system and CathVision Cube® System were running on two different PCs in the EP laboratory in parallel. The relevant EGM snippets were extracted from the conventional EP system using a time offset between the conventional EP system PC and the Cube PC. Since a very similar number of samples were used to compute the results, no statistical assessment of the sampling variation in the sensitivity and specificity was made. A paired McNemars test, with an alpha value of 0.05, was applied to analyze the differences in classification performance.
Outcome measures
| Measure |
Single Group
n=297 Electrogram (EGM)
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.
|
Cryoballoon Procedure
n=295 Electrogram (EGM)
Index EP Procedure: Ablation of atrial fibrillation according to Cryo-ballon Procedure: cryo-balloon ablates the tissue through freezing.
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.
|
Pulsed Field Ablation (PFA) Procedure
PFA delivers short high-voltage pulses that ablates through irreversible electroporation.
The data obtained from pulsed field ablation (PFA) analysis could not be assessed for this secondary endpoint as it was found to be incompatible with the PVI Analyzer algorithm, which requires the PV mapping catheter to have eight or ten electrodes and the PFA catheter has only five.
|
|---|---|---|---|
|
Comparison of the PVI Analyzer Performance With CathVision Cube® System Data With Its Performance With Data From Other Conventional EP Systems Used
Specificity
|
118 Electrogram (EGM)
|
127 Electrogram (EGM)
|
—
|
|
Comparison of the PVI Analyzer Performance With CathVision Cube® System Data With Its Performance With Data From Other Conventional EP Systems Used
Sensitivity
|
103 Electrogram (EGM)
|
124 Electrogram (EGM)
|
—
|
Adverse Events
Adult Patients With Cardiac Arrhythmia Undergoing Cryoballoon
Adult Patients With Cardiac Arrhythmia Undergoing Radiofrequency
Adult Patients With Cardiac Arrhythmia Undergoing Pulsed Field Ablation
Serious adverse events
| Measure |
Adult Patients With Cardiac Arrhythmia Undergoing Cryoballoon
n=47 participants at risk
Safety was evaluated in adult patients diagnosed with cardiac arrhythmia, including patients with supraventricular tachycardia and ventricular tachycardia undergoing Cryoballoon procedure
|
Adult Patients With Cardiac Arrhythmia Undergoing Radiofrequency
n=42 participants at risk
Safety was evaluated in adult patients diagnosed with cardiac arrhythmia, including patients with supraventricular tachycardia and ventricular tachycardia undergoing Radiofrequency procedure
|
Adult Patients With Cardiac Arrhythmia Undergoing Pulsed Field Ablation
n=12 participants at risk
Safety was evaluated in adult patients diagnosed with cardiac arrhythmia, including patients with supraventricular tachycardia and ventricular tachycardia undergoing Pulsed Field Ablation procedure
|
|---|---|---|---|
|
Surgical and medical procedures
Prolongation of an existing hospitalization
|
0.00%
0/47 • Adverse events data were collected from participants' electrophysiology procedure until study completion at discharge (hospitalization time approximately 1-2 days).
The assessment of the PVI Analyzer software analysis was performed offline and retrospectively, the AEs related to the device and device malfunctions reported were expected to be minimal or even absent. Determination of whether the investigational product contributed to an AE is to be determined by the Investigator. All efforts were made by the investigator to remain alert to possible AEs.
|
2.4%
1/42 • Adverse events data were collected from participants' electrophysiology procedure until study completion at discharge (hospitalization time approximately 1-2 days).
The assessment of the PVI Analyzer software analysis was performed offline and retrospectively, the AEs related to the device and device malfunctions reported were expected to be minimal or even absent. Determination of whether the investigational product contributed to an AE is to be determined by the Investigator. All efforts were made by the investigator to remain alert to possible AEs.
|
0.00%
0/12 • Adverse events data were collected from participants' electrophysiology procedure until study completion at discharge (hospitalization time approximately 1-2 days).
The assessment of the PVI Analyzer software analysis was performed offline and retrospectively, the AEs related to the device and device malfunctions reported were expected to be minimal or even absent. Determination of whether the investigational product contributed to an AE is to be determined by the Investigator. All efforts were made by the investigator to remain alert to possible AEs.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place