Catheter Ablation Using a Novel Navigation and Imaging System

N/ANot Yet RecruitingNCT06895187

LUMA Vision Ltd.100 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Paroxysmal Atrial Fibrillation

Interventions

VERAFEYE SystemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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:

Outcomes

Primary Outcomes

Acute procedural success rates during the index 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

Time frame: During the procedure

Central Contacts

Elke Sommerijns

CONTACT

+32479767156 elke.sommerijns@lumavision.com

Alisa Komleva

CONTACT

+353894352047 alisa.komleva@lumavision.com

Data from ClinicalTrials.gov

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