Clinical trial NCT06772493: ViewFlex X ICE First-in-Human Study
Official title: ViewFlex X ICE First-in-Human Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Arrhythmias
Keywords: Intracardiac Echocardiography
cardiac electrophysiology
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2025-01-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This clinical investigation will enroll subjects of all genders over the age of 18 undergoing any previously planned electrophysiology study procedure utilizing ICE.

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

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

1. Able and willing to provide written informed consent prior to any clinical investigation-related procedure.
2. Plans to undergo any EP procedure utilizing ICE
3. 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:

1. Subject is currently participating in another clinical investigation.
2. Implanted left atrial appendage occluder
3. Implanted mechanical mitral or tricuspid valve replacement
4. Implanted intracardiac device within 30 days
5. Pregnant or nursing
6. 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.

Primary outcomes:
measure: Physician assessment of the ability to navigate the ViewFlex X SE catheter and adequately visualize major cardiac anatomic structures.
timeFrame: During the procedure
measure: Physician assessment of the ability to use anatomic ICE markers and ICE geometry as a reference during mapping and ablation procedures.
timeFrame: during the procedure
measure: Rate of device- or procedure-related serious adverse events that occur through patient discharge.
timeFrame: during the procedure and periprocedurally
Secondary outcomes:
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: St. Bernards Medical Center
state: Arkansas
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Abbott
name: Kristin Ruffner, PhD
role: STUDY_DIRECTOR
References: