Paroxysmal Atrial Fibrillation
Conditions
Brief summary
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).
Interventions
DEVICEVERAFEYE System
VERAFEYE system guidance will be used on all patients undergoing PAF ablation.
Sponsors
LUMA Vision Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute procedural success rates during the index procedure | During the procedure | A procedure will be defined as successful if all the following conditions occur during the case: * ability to create a 3D anatomical model with the VERAFEYE System and * completion of the necessary ablation applications for PAF using the 3D anatomical model created with the VERAFEYE System |
Contacts
CONTACTElke Sommerijns
CONTACTAlisa Komleva
Outcome results
None listed