Catheter Ablation Using a Novel Navigation and Imaging System

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).

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VERAFEYE System

Device

VERAFEYE system guidance will be used on all patients undergoing PAF ablation.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alisa Komleva

CONTACT

[email protected]

+353894352047

Elke Sommerijns

CONTACT

[email protected]

+32479767156

Sponsors and collaborators

Lead sponsor

LUMA Vision Ltd.

Industry

Registry information

Acronym: ENVIsIoN

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Mar 26, 2025
Registry last updated: Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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