NCT06895187Not yet recruitingNot Applicable
Catheter Ablation Using a Novel Navigation and Imaging System
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- LUMA Vision Ltd.
- Enrollment
- 100
- Primary Endpoint
- Acute procedural success rates during the index procedure
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Acute procedural success rates during the index procedure
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
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