Catheter Ablation Using a Novel Navigation and Imaging System (ENVIsIoN)

LUMA Vision

Status: Begins enrollment in 4 months

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: VERAFEYE System

Study type: Observational

Funder types: Industry

Identifiers

NCT06895187

ENVISION-P003

Details and patient eligibility

About

The objective of the ENVIsIoN study is to collect data on the use of the VERAFEYE navigation and imaging system in patients indicated to undergo a catheter ablation procedure for the treatment of Paroxysmal Atrial Fibrillation (PAF).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Subject is 18 years of age at the time of consent, or of legal age to give informed consent specific to state and national law
• Subjects is eligible for a catheter ablation procedure with the VERAFEYE System as navigation and imaging system in the treatment of PAF (according to VERAFEYE System IFUs, current international and local guidelines and per physician discretion)
• Subject is able to understand and willing to provide written informed consent
• Subject is able to and willing to complete all study assessments associated with this clinical study at an approved clinical investigational center

Exclusion Criteria: