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Not yet recruiting NCT06293430

Registry on Luma Vision's VERAFEYE System (ENLIgHT)

— Observational Atrial Fibrillation Left Atrial Appendage Closure Atrial Arrhythmia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VERAFEYE System.
Who it may be relevant to
Registry conditions: Atrial Fibrillation, Left Atrial Appendage Closure, Atrial Arrhythmia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Registry on Luma Vision's VERAFEYE System in Catheter Ablation and Left Atrial Appendage Closure Procedures

Overview

The objective of the study is to compile real-world data on the use of the VERAFEYE System in standard of care atrial fibrillation (AF) ablation procedures and left atrial appendage closure (LAAC) procedures.

Interventions

  • Device VERAFEYE System
    VERAFEYE system guidance will be used on all patients undergoing AF ablation and/or LAAC procedures.

Primary outcome measures

  • Acute procedural success rates during the index procedure [Time frame: During the procedure]

Eligibility criteria

Inclusion criteria

  • Subject is 18 years of age or of legal age to give informed consent specific to state and national law at the time of consent
  • Subjects is indicated for an atrial fibrillation ablation and/or a left atrial appendage closure procedure with the VERAFEYE System as navigation and imaging system, per physician discretion;
  • Subject is able to understand and willing to provide written informed consent
  • Subject is able and willing to complete all study assessments at an approved clinical investigational center

Exclusion criteria

  • Subjects who have undergone a previous cardiac ablation for the treatment of PAF/LAA Closure
  • Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion
  • Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the procedure)
  • Unrecovered/unresolved Adverse Events from any previous invasive procedure
  • Subjects who are currently enrolled in another study (except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06293430 · ENLIgHT-P002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗