Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures (INSiGHT)

LUMA Vision

Status

Begins enrollment in 1 month

Conditions

Atrial Flutter

Atrial Fibrillation

Atrial Arrhythmia

Treatments

Device: VERAFEYE Imaging and Guidance System

Study type

Interventional

Funder types

Industry

Identifiers

NCT07271238

INSiGHT-P005

Details and patient eligibility

About

The objective of the study is to collect data on the usability and integration of the VERAFEYE Imaging and Guidance System in adult patients indicated to undergo a standard of care catheter-based ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF).

Results from this study may be used to guide development and refinement the VERAFEYE Imaging and Guidance System capabilities.

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 standard of care 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: Subject implanted with an active cardiac rhythm management device (e.g. pacemaker, CRT, ICD)
EC4: Unrecovered/unresolved Adverse Events from any previous invasive procedure
EC5: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure
EC6: Life expectancy less than 12 months
EC7: 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.
EC8: Subjects who are currently enrolled in another study