An interventional study of CathVision Cube® system in Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, sponsored by CathVision ApS. Completed at 4 sites in 2 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by CathVision ApS · Not applicable, Interventional, and Treatment
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.
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.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's enrollment of 101 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →CathVision ApS is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
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Eligible subjects will meet all of the following inclusion criteria:
Eligible subjects will not meet any of the following exclusion criteria:
Index EP Procedure: Ablation of atrial fibrillation
Device: 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.
PVI Analyzer Sensitivity and Specificity, Measured as the Accuracy of Predictions for Non-isolated and Isolated Veins.
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.
Time frame: From EP procedure until study completion at discharge; an average of 24 hours.
PVI Analyzer Safety Profile, Measured as the Number of Adverse Events and/or Device Malfunctions.
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.
Time frame: From EP procedure until study completion at discharge; an average of 24 hours.
The Pulmonar Vein Isolation (PVI) Classification in Sinus Rhythm (SR) Considering the Electrophysiology Procedure Type.
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.
Time frame: From EP procedure until study completion at discharge; an average of 24 hours.
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.
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.
Time frame: From EP procedure until study completion at discharge; an average of 24 hours.
PVI Isolation Classification in Non-sinus Rhythm (NSR) From EP Procedure
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.
Time frame: From EP procedure until study completion at discharge; an average of 24 hours.
Accuracy of PVI Analyzer Classification at the Time of Expert-defined Isolation
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.
Time frame: From EP procedure until study completion at discharge; an average of 24 hours.
Comparison of the PVI Analyzer Performance With CathVision Cube® System Data With Its Performance With Data From Other Conventional EP Systems Used
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.
Time frame: From EP procedure until study completion at discharge; an average of 24 hours.
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.
| Milestone | Index EP Procedure: Ablation of Atrial Fibrillation |
|---|---|
| Started | 101 |
| Completed | 97 |
| Not completed | 4 |
| Withdrew: Minimum required measurements could not be taken | 4 |
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.
| Electrogram (EGM) | Single Group |
|---|---|
| Sensitivity | 216 |
| Specificity | 215 |
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.
| participants | Single Group |
|---|---|
| Mild | 0 |
| Moderate | 1 |
| Severe | 0 |
| Device related | 0 |
| Procedure related | 1 |
| other | 0 |
| Serious Adverse Events | 1 |
| Serious adverse device effect (SADE) incidence | 0 |
| Serious unanticipated serious adverse device effect (USADE) incidence | 0 |
| Device deficiency incidence | 0 |
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.
| Electrogram (EGM) | Radiofrequency Procedure | Cryoballoon Procedure | Pulsed Field Ablation (PFA) Procedure |
|---|---|---|---|
| Specificty | 120 | 95 | 0 |
| Sensitivity | 107 | 109 | 0 |
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.
| Electrogram (EGM) | Index EP Procedure: Ablation of Atrial Fibrillation |
|---|---|
| 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 |
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.
| Electrogram (EGM) | Index EP Procedure: Ablation of Atrial Fibrillation |
|---|---|
| Specificity | 25 |
| Sensitivity | 41 |
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.
| Electrogram (EGM) | Index EP Procedure: Ablation of Atrial Fibrillation |
|---|---|
| Accuracy of PVI Analyzer Classification at the Time of Expert-defined Isolation | 86 |
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.
| Electrogram (EGM) | Conventional EP System | CathVision Cube® System |
|---|---|---|
| Specificity | 118 | 127 |
| Sensitivity | 103 | 124 |
Collected over Adverse events data were collected from participants' electrophysiology procedure until study completion at discharge (hospitalization time approximately 1-2 days).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adult Patients With Cardiac Arrhythmia Undergoing Cryoballoon | 0/47 (0%) | 0/47 (0%) | 0/47 (0%) |
| Adult Patients With Cardiac Arrhythmia Undergoing Radiofrequency | 0/42 (0%) | 1/42 (2.4%) | 0/42 (0%) |
| Adult Patients With Cardiac Arrhythmia Undergoing Pulsed Field Ablation | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Event | Adult Patients With Cardiac Arrhythmia Undergoing Cryoballoon | Adult Patients With Cardiac Arrhythmia Undergoing Radiofrequency | Adult Patients With Cardiac Arrhythmia Undergoing Pulsed Field Ablation |
|---|---|---|---|
| Prolongation of an existing hospitalizationSurgical and medical procedures | 0/47 | 1/42 | 0/12 |
| Age, Continuous(years) | Index EP Procedure: Ablation of Atrial Fibrillation |
|---|---|
| Mean | 62.76 ± 12.31 |
| Sex: Female, Male(Participants) | Index EP Procedure: Ablation of Atrial Fibrillation |
|---|---|
| Female | 37 |
| Male | 64 |
| Race and Ethnicity Not Collected(Participants) | Index EP Procedure: Ablation of Atrial Fibrillation |
|---|
| Height [cm](cm) | Index EP Procedure: Ablation of Atrial Fibrillation |
|---|---|
| Mean | 174.23 ± 9.83 |
| Weight [kg](kg) | Index EP Procedure: Ablation of Atrial Fibrillation |
|---|---|
| Mean | 82.04 ± 17.86 |
| Systolic Blood Pressure [mmHg](mmHg) | Index EP Procedure: Ablation of Atrial Fibrillation |
|---|---|
| Mean | 137.39 ± 20.04 |
| Diastolic Blood Pressure [mmHg](mmHg) | Index EP Procedure: Ablation of Atrial Fibrillation |
|---|---|
| Mean | 79.44 ± 12.10 |
| Heart Rate [BPM](BPM) | Index EP Procedure: Ablation of Atrial Fibrillation |
|---|---|
| Mean | 72.69 ± 22.40 |
2 further baseline measures are reported on the registry.
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