Catheter Ablation Using a Novel Navigation and Imaging System

NCT ID: NCT06895187

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-07-01

Study Completion Date

2027-07-01

Brief Summary

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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

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Conditions

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Paroxysmal Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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VERAFEYE System

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LUMA Vision Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Elke Sommerijns

Role: CONTACT

+32479767156

Alisa Komleva

Role: CONTACT

+353894352047

Other Identifiers

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ENVISION-P003

Identifier Type: -

Identifier Source: org_study_id

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