Paroxysmal Atrial FibrillationPVISIONNCT05043883

Automated Assessment of PVI Using a Novel EP Recording System

A study testing CathVision Cube® system in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by CathVision ApS at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
What is being tested?: CathVision Cube® system
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 101 participants
Where: 4 sitesin 2 countries
Study dates: 15 Sep 2021to 22 Jun 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Belgium3 sites

AZ Sint-Jan Hospital
Bruges, 8000
Universitair Ziekenhuis Brussel
Brussels, 1090
Ghent University Hospital
Ghent, 9000

Other trials in Belgium

France1 site

Clinique Pasteur Toulouse,
Toulouse, 31300

Other trials in France

About this study

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

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.

Read the detailed description

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.

Conditions: Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Being tested: CathVision Cube® system
Keywords: atrial fibrillation, pulmonary vein isolation, radiofrequency, cryo balloon, ablation, software, pulse field ablation
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CathVision Cube® systemDevice
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.

Study groups in NCT05043883
Study group	Role	What they receive
Single Group	Experimental	Index EP Procedure: Ablation of atrial fibrillation Receives: Device: CathVision Cube® system

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: From EP procedure until study completion at discharge; an average of 24 hours.

Secondary outcomes (5)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From EP procedure until study completion at discharge; an average of 24 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 202122 Jun 2022

First posted14 Sep 2021
Study start15 Sep 2021
Primary completion22 Jun 2022
Study completion22 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05043883
Sponsor's protocol ID: CPVI-002
Acronym: PVISION
Status last verified: Mar 2024
First submitted: 3 Aug 2021
Last updated: 9 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

De Pooter J, Timmers L, Boveda S, Combes S, Knecht S, Almorad A, De Asmundis C, Duytschaever M. Validation of a machine learning algorithm to identify pulmonary vein isolation during ablation procedures for the treatment of atrial fibrillation: results of the PVISION study. Europace. 2024 May 2;26(5):euae116. doi: 10.1093/europace/euae116.
PubMed 38682165

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Paroxysmal Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Automated Assessment of Pulmonary Vein Isolation (PVI) Using a Novel EP Recording System (CathVision Cube® System)
ClinicalTrials.gov ID: NCT05043883
Acronym / sponsor ID: PVISION / CPVI-002
Conditions: Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Keywords: atrial fibrillation, pulmonary vein isolation, radiofrequency, cryo balloon, ablation, software, pulse field ablation
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: CathVision ApSIndustry (pharma, biotech, devices)
Collaborators: AKRN Scientific Consulting, S.L.
Study start: 15 Sep 2021 (actual)
Primary completion: 22 Jun 2022 (actual)
Study completion: 22 Jun 2022 (actual)
First posted: 14 Sep 2021 (actual)
Results: Posted 9 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Group	Experimental	Device: CathVision Cube® systemIndex EP Procedure: Ablation of atrial fibrillation

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CathVision Cube® systemIntracardiac 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.	Device	Single Group

Primary outcome

PVI Analyzer Sensitivity and Specificity, Measured as the Accuracy of Predictions for Non-isolated and Isolated Veins.
Time frame: From EP procedure until study completion at discharge; an average of 24 hours.
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.
PVI Analyzer Safety Profile, Measured as the Number of Adverse Events and/or Device Malfunctions.
Time frame: From EP procedure until study completion at discharge; an average of 24 hours.
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.

5 secondary outcomes

The Pulmonar Vein Isolation (PVI) Classification in Sinus Rhythm (SR) Considering the Electrophysiology Procedure Type.
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.
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
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
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
Time frame: From EP procedure until study completion at discharge; an average of 24 hours.

Results and safety

Results posted to the registry on 9 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Index EP Procedure: Ablation of Atrial Fibrillation	101	97

Primary outcome: PVI Analyzer Sensitivity and Specificity, Measured as the Accuracy of Predictions for Non-isolated and Isolated Veins.

Time frame: From EP procedure until study completion at discharge; an average of 24 hours.. Count of units. Unit: Electrogram (EGM)

Measure	Single Group n = 85
Sensitivity	216
Specificity	215

Single Group: Percentage (%): 87, p = 0.006, Z-test
Single Group: Percentage: 86, p = 0.004, Z-test

Population analysed: 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).

Primary outcome: PVI Analyzer Safety Profile, Measured as the Number of Adverse Events and/or Device Malfunctions.

Time frame: From EP procedure until study completion at discharge; an average of 24 hours.. Number. Unit: participants

Measure	Single Group n = 101
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

Single Group: Percentage: 0.99 (95% CI 0.02 to 5.39)

Population analysed: All enrolled subjects.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events data were collected from participants' electrophysiology procedure until study completion at discharge (hospitalization time approximately 1-2 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adult Patients With Cardiac Arrhythmia Undergoing Cryoballoon	0 of 47 (0%)	0 of 47 (0%)	0 of 47
Adult Patients With Cardiac Arrhythmia Undergoing Radiofrequency	1 of 42 (2.4%)	0 of 42 (0%)	0 of 42
Adult Patients With Cardiac Arrhythmia Undergoing Pulsed Field Ablation	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Limitations and caveats (from the sponsor): Only a limited amount of data (30 seconds) could be exported from the LS Pro system, which limited the correlation to only search a narrow region around the exported EGM data. The data obtained from the PFA procedures could not be assessed due to incompatibility with the PVI Analyzer algorithm.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38682165De Pooter J, Timmers L, Boveda S, Combes S, Knecht S, Almorad A, De Asmundis C, Duytschaever M. Validation of a machine learning algorithm to identify pulmonary vein isolation during ablation procedures for the treatment of atrial fibrillation: results of the PVISION study. Europace. 2024 May 2;26(5):euae116. doi: 10.1093/europace/euae116.
Individual participant dataSharing planned: No

Related trials for Paroxysmal Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
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RecruitingObservational study
A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation
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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mattias Duytschaever, Prof. MD PhD principal investigator

AZ Sint-Jan Hospital, Ruddershove 10 8000 Brugge, Belgium

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CathVision Cube® system in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by CathVision ApS at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PVI Analyzer Sensitivity and Specificity, Measured as the Accuracy of Predictions for Non-isolated and Isolated Veins. (time frame: From EP procedure until study completion at discharge; an average of 24 hours.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05043883, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.