Not Yet RecruitingNot Applicable

Catheter Ablation Using a Novel Navigation and Imaging System

100 participantsStarted 2026-09-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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:

What they're measuring

Acute procedural success rates during the index procedure

Timeframe: During the procedure

Trial details

NCT IDNCT06895187

SponsorLUMA Vision Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-09-01

Contact for this trial

Elke Sommerijns

+32479767156 elke.sommerijns@lumavision.com

View on ClinicalTrials.gov More Paroxysmal Atrial Fibrillation trials