Catheter Ablation Using a Novel Navigation and Imaging System
- Conditions
- Paroxysmal Atrial Fibrillation
- Registration Number
- NCT06895187
- Lead Sponsor
- LUMA Vision Ltd.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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