Automated Assessment of PVI Using a Novel EP Recording System

NCT05043883 | Completed Results

• 1 other identifier: CPVI-002
• Study Type: interventional
• Target: 101
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Keywords

atrial fibrillation; pulmonary vein isolation; radiofrequency; cryo balloon; ablation; software; pulse field ablation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

  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.

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

• PVI Isolation Classification in Non-sinus Rhythm (NSR) From EP Procedure

  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

  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

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

Study Arms (1)

Single Group

EXPERIMENTAL

Index EP Procedure: Ablation of atrial fibrillation

Device: CathVision Cube® system

Interventions

CathVision Cube® system DEVICE

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.

Single Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CathVision ApS: lead
• AKRN Scientific Consulting, S.L.: collaborator

Study Sites (4)

AZ Sint-Jan Hospital

Bruges, 8000, Belgium

Location

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

Clinique Pasteur Toulouse,

Toulouse, 31300, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Mads Matthiesen
• Organization: CathVision

mem@cathvision.com

+4531470730

Study Officials

• Mattias Duytschaever, Prof. MD PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: September 14, 2021
• Study Start: September 15, 2021
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3); FR (1)