Catheter Ablation Using a Novel Navigation and Imaging System

NCT06895187 | Not Yet Recruiting FDA Device

• 1 other identifier: ENVISION-P003
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

  During the procedure

Interventions

VERAFEYE System DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Subjects who have undergone a previous cardiac ablation for the treatment of PAF * 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)

You may qualify if:

• 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

Sponsors & Collaborators

• LUMA Vision Ltd.: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Elke Sommerijns

CONTACT

+32479767156; elke.sommerijns@lumavision.com

Alisa Komleva

CONTACT

+353894352047; alisa.komleva@lumavision.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 26, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share