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Not yet recruiting NCT06895187

Catheter Ablation Using a Novel Navigation and Imaging System

— Observational Paroxysmal Atrial Fibrillation

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: Paroxysmal Atrial Fibrillation. 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 →

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).

Interventions

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

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 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

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: NCT06895187 · ENVISION-P003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗