Automated Assessment of PVI Using a Novel EP Recording System

NACompletedINTERVENTIONAL
Enrollment

101

Participants

Timeline

Start Date

September 15, 2021

Primary Completion Date

June 22, 2022

Study Completion Date

June 22, 2022

Conditions
Paroxysmal Atrial FibrillationPersistent Atrial Fibrillation
Interventions
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.

Trial Locations (4)

1090

Universitair Ziekenhuis Brussel, Brussels

8000

AZ Sint-Jan Hospital, Bruges

9000

Ghent University Hospital, Ghent

31300

Clinique Pasteur Toulouse,, Toulouse

Sponsors
All Listed Sponsors
collaborator

AKRN Scientific Consulting, S.L.

INDUSTRY

lead

CathVision ApS

INDUSTRY

NCT05043883 - Automated Assessment of PVI Using a Novel EP Recording System | Biotech Hunter | Biotech Hunter