Anatomical Navigation for Guided Electrophysiology in AFL and AFib (ANGEL-AF)

LUMA Vision

Status

Enrolling

Conditions

Atrial Flutter

Atrial Fibrillation

Atrial Arrhythmia

Treatments

Device: VERAFEYE Anatomic Guidance System

Study type

Interventional

Funder types

Industry

Identifiers

NCT07210151

ANGEL-AF -P004

Details and patient eligibility

About

The objective of the study is to collect data on the use of the VERAFEYE Anatomical Guidance System in adult patients indicated to undergo a catheter ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF).

The study will collect specific information on management of AFL/AF ablation procedures with the commercial VERAFEYE Anatomical Guidance System including but not limited to acute procedural success , and how the VERAFEYE Anatomical Guidance System is used overall. Results from this study may be used to guide development and refinement the VERAFEYE Anatomical Guidance System.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

IC1: Subject is at least 18 years of age at the time of consent
IC2: Subject is scheduled to undergo a catheter-ablation procedure to treat AFL/AF (*according to current international and local guidelines and per physician discretion)
IC3: Subject is able to understand and willing to provide written informed consent
IC4: Subject is able and willing to complete all study assessments associated with this clinical study at an approved clinical study site

Exclusion criteria

EC1: Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion
EC2: 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)
EC3: Unrecovered/unresolved Adverse Events from any previous invasive procedure
EC4: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure.
EC5: Life expectancy less than 12 months
EC6: Current LA thrombus

Note: Screening for LA thrombus is required to be performed within 48 hours prior to or during the index procedure. Method of screening per physician discretion. If an atrial thrombus is observed prior to or during the planned index procedure, the index procedure will not begin or will be terminated before accessing the left atrium, and no ablation will be performed. The index procedure for this subject may be rescheduled to be performed within 30 days post ICF signature, provided that the thrombus is no longer present.