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Automated Assessment of PVI Using a Novel EP Recording System (PVISION)

Primary Purpose

Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CathVision Cube® system
Sponsored by
CathVision ApS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring atrial fibrillation, pulmonary vein isolation, radiofrequency, cryo balloon, ablation, software, pulse field ablation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AZ Sint-Jan Hospital
  • Universitair Ziekenhuis Brussel
  • Ghent University Hospital
  • Clinique Pasteur Toulouse,

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Group

Arm Description

Index EP Procedure: Ablation of atrial fibrillation

Outcomes

Primary Outcome Measures

The primary performance objective is to validate the PVI Analyzer software with a novel EP recording system (CathVision Cube® System) for assessment of isolation status following PVI ablation.
Sensitivity and specificity of PVI Analyzer classification of isolation status following PVI ablation using data from the investigational CathVision Cube System. Specificity is defined as the ratio of correct negative (non-isolated) predictions among data points from non-isolated veins. Sensitivity is defined as the ratio of correct positive (isolated) data points from isolated veins. Classification is performed using recorded data before and after the isolation of each available pulmonary vein independently.
The safety endpoint of the Study will evaluate the adverse events and/or device malfunctions reported with the use of the CathVision Cube® System.
Evaluation of adverse events and/or device malfunctions reported with the use of the CathVision Cube® System during the procedure until discharge.

Secondary Outcome Measures

Accuracy of automated PVI Analyzer classification of PV isolation in SR during Cryo-balloon ablation
Sensitivity and specificity of PVI Analyzer classification of isolation status within the Cryo-balloon ablation subgroup. Classification, sensitivity and specificity are defined in the same way as for the primary endpoint.
Accuracy of automated PVI Analyzer classification of PV isolation in SR during RF ablation
Sensitivity and specificity of PVI Analyzer classification of isolation status within the RF ablation subgroup. Classification, sensitivity and specificity are defined in the same way as for the primary endpoint.
Assessment of automated PVI Analyzer classification of PV isolation in SR after PFA
Sensitivity and specificity of PVI Analyzer classification of isolation status within the PFA ablation subgroup. Classification, sensitivity and specificity are defined in the same way as for the primary endpoint.
Feasibility of "real-time" assessment of isolation
Retest accuracy of PVI Analyzer classification of isolation status at different timepoints before, during and after ablation. The accuracy is defined as the agreement of re-classification of pairs of non-overlapping samples before, during and after ablation.
Automated PVI Analyzer classification of PV isolation in NSR
Sensitivity and specificity of PVI Analyzer classification of isolation status within the subgroup of data recorded in non-sinus rhythm. Non-sinus rhythm is defined as any rhythm not regarded as sinus rhythm, including atrial fibrillation, typical- and atypical atrial flutter. Classification, sensitivity and specificity are measured in the same way as for primary endpoint.
PVI Analyzer classification accuracy at the time of expert-defined isolation
Sensitivity of PVI Analyzer analysis to identify expert-defined isolation during PVI ablation.
Comparison of device performance with conventional system
Specificity and sensitivity of PVI Analyzer analysis to identify isolation using data from the conventional system.

Full Information

First Posted
August 3, 2021
Last Updated
July 19, 2022
Sponsor
CathVision ApS
Collaborators
AKRN Scientific Consulting, S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT05043883
Brief Title
Automated Assessment of PVI Using a Novel EP Recording System
Acronym
PVISION
Official Title
Automated Assessment of Pulmonary Vein Isolation (PVI) Using a Novel EP Recording System (CathVision Cube® System)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
June 22, 2022 (Actual)
Study Completion Date
June 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CathVision ApS
Collaborators
AKRN Scientific Consulting, S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Keywords
atrial fibrillation, pulmonary vein isolation, radiofrequency, cryo balloon, ablation, software, pulse field ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Group
Arm Type
Experimental
Arm Description
Index EP Procedure: Ablation of atrial fibrillation
Intervention Type
Device
Intervention Name(s)
CathVision Cube® system
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary performance objective is to validate the PVI Analyzer software with a novel EP recording system (CathVision Cube® System) for assessment of isolation status following PVI ablation.
Description
Sensitivity and specificity of PVI Analyzer classification of isolation status following PVI ablation using data from the investigational CathVision Cube System. Specificity is defined as the ratio of correct negative (non-isolated) predictions among data points from non-isolated veins. Sensitivity is defined as the ratio of correct positive (isolated) data points from isolated veins. Classification is performed using recorded data before and after the isolation of each available pulmonary vein independently.
Time Frame
From EP procedure until study completion at discharge; an average of 24 hours.
Title
The safety endpoint of the Study will evaluate the adverse events and/or device malfunctions reported with the use of the CathVision Cube® System.
Description
Evaluation of adverse events and/or device malfunctions reported with the use of the CathVision Cube® System during the procedure until discharge.
Time Frame
From EP procedure until study completion at discharge; an average of 24 hours.
Secondary Outcome Measure Information:
Title
Accuracy of automated PVI Analyzer classification of PV isolation in SR during Cryo-balloon ablation
Description
Sensitivity and specificity of PVI Analyzer classification of isolation status within the Cryo-balloon ablation subgroup. Classification, sensitivity and specificity are defined in the same way as for the primary endpoint.
Time Frame
From EP procedure until study completion at discharge; an average of 24 hours.
Title
Accuracy of automated PVI Analyzer classification of PV isolation in SR during RF ablation
Description
Sensitivity and specificity of PVI Analyzer classification of isolation status within the RF ablation subgroup. Classification, sensitivity and specificity are defined in the same way as for the primary endpoint.
Time Frame
From EP procedure until study completion at discharge; an average of 24 hours.
Title
Assessment of automated PVI Analyzer classification of PV isolation in SR after PFA
Description
Sensitivity and specificity of PVI Analyzer classification of isolation status within the PFA ablation subgroup. Classification, sensitivity and specificity are defined in the same way as for the primary endpoint.
Time Frame
From EP procedure until study completion at discharge; an average of 24 hours.
Title
Feasibility of "real-time" assessment of isolation
Description
Retest accuracy of PVI Analyzer classification of isolation status at different timepoints before, during and after ablation. The accuracy is defined as the agreement of re-classification of pairs of non-overlapping samples before, during and after ablation.
Time Frame
From EP procedure until study completion at discharge; an average of 24 hours.
Title
Automated PVI Analyzer classification of PV isolation in NSR
Description
Sensitivity and specificity of PVI Analyzer classification of isolation status within the subgroup of data recorded in non-sinus rhythm. Non-sinus rhythm is defined as any rhythm not regarded as sinus rhythm, including atrial fibrillation, typical- and atypical atrial flutter. Classification, sensitivity and specificity are measured in the same way as for primary endpoint.
Time Frame
From EP procedure until study completion at discharge; an average of 24 hours.
Title
PVI Analyzer classification accuracy at the time of expert-defined isolation
Description
Sensitivity of PVI Analyzer analysis to identify expert-defined isolation during PVI ablation.
Time Frame
From EP procedure until study completion at discharge; an average of 24 hours.
Title
Comparison of device performance with conventional system
Description
Specificity and sensitivity of PVI Analyzer analysis to identify isolation using data from the conventional system.
Time Frame
From EP procedure until study completion at discharge; an average of 24 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mattias Duytschaever, Prof. MD PhD
Organizational Affiliation
AZ Sint-Jan Hospital, Ruddershove 10 8000 Brugge, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Sint-Jan Hospital
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Clinique Pasteur Toulouse,
City
Toulouse
ZIP/Postal Code
31300
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Automated Assessment of PVI Using a Novel EP Recording System

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