ViewFlex X ICE First-in-Human Study (ViewFlex X FIH)

Abbott

Status

Enrolling

Conditions

Cardiac Arrhythmias

Treatments

Device: ViewFlex X ICE System

Study type

Observational

Funder types

Industry

Identifiers

NCT06772493

ABT-CIP-10528

Details and patient eligibility

About

This prospective, acute, first-in-human, non-significant risk study is intended to evaluate a modified version of the ViewFlex X ICE Catheter, Sensor Enabled (ViewFlex X SE) and ViewMate Multi Ultrasound Console (VMM) ICE data integration with the EnSite X EP System (hereafter referred to as the ViewFlex X ICE System).

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A patient will be eligible for clinical trial participation if they meet the following criteria:

Able and willing to provide written informed consent prior to any clinical investigation-related procedure.
Plans to undergo any EP procedure utilizing ICE
At least 18 years of age

Exclusion criteria

A patient will be excluded from enrollment in the study if they meet any of the following criteria:

Subject is currently participating in another clinical investigation.
Implanted left atrial appendage occluder
Implanted mechanical mitral or tricuspid valve replacement
Implanted intracardiac device within 30 days
Pregnant or nursing
Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.