Clinical trial NCT05043883: Automated Assessment of PVI Using a Novel EP Recording System
Official title: Automated Assessment of Pulmonary Vein Isolation (PVI) Using a Novel EP Recording System (CathVision Cube® System)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Keywords: atrial fibrillation
pulmonary vein isolation
radiofrequency
cryo balloon
ablation
software
pulse field ablation
Lead sponsor: CathVision ApS
Sponsor class: INDUSTRY
Collaborators: name: AKRN Scientific Consulting, S.L.
First posted: 2021-09-14
Enrollment: 101
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Eligible subjects will meet all of the following inclusion criteria:

1. Subjects undergoing first-time pulmonary vein isolation indicated by investigator for the treatment of atrial fibrillation
2. Male or non-pregnant female aged ≥21 years.
3. 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:

1. Pregnant or nursing subjects.
2. Current participation in another investigational drug or device study that interferes with this Study.
3. Subjects who, in the opinion of the investigator, are not candidates for this Study.
4. Patients who have had a prior ablation procedure
5. 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.
6. Life expectancy less than 12 month
7. Subjects who, in the opinion of the investigator, are considered part of any vulnerable population.

Primary outcomes:
measure: PVI Analyzer Sensitivity and Specificity, Measured as the Accuracy of Predictions for Non-isolated and Isolated Veins.
timeFrame: From EP procedure until study completion at discharge; an average of 24 hours.
measure: PVI Analyzer Safety Profile, Measured as the Number of Adverse Events and/or Device Malfunctions.
timeFrame: From EP procedure until study completion at discharge; an average of 24 hours.
Secondary outcomes:
measure: The Pulmonar Vein Isolation (PVI) Classification in Sinus Rhythm (SR) Considering the Electrophysiology Procedure Type.
timeFrame: From EP procedure until study completion at discharge; an average of 24 hours.
measure: 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.
timeFrame: From EP procedure until study completion at discharge; an average of 24 hours.
measure: PVI Isolation Classification in Non-sinus Rhythm (NSR) From EP Procedure
timeFrame: From EP procedure until study completion at discharge; an average of 24 hours.
measure: Accuracy of PVI Analyzer Classification at the Time of Expert-defined Isolation
timeFrame: From EP procedure until study completion at discharge; an average of 24 hours.
measure: Comparison of the PVI Analyzer Performance With CathVision Cube® System Data With Its Performance With Data From Other Conventional EP Systems Used
timeFrame: From EP procedure until study completion at discharge; an average of 24 hours.
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ Sint-Jan Hospital
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Toulouse
country: France
facility: Clinique Pasteur Toulouse,
Study officials:
affiliation: AZ Sint-Jan Hospital, Ruddershove 10 8000 Brugge, Belgium
name: Mattias Duytschaever, Prof. MD PhD
role: PRINCIPAL_INVESTIGATOR
References: