Cardiac Arrhythmias
Conditions
Keywords
Intracardiac Echocardiography, cardiac electrophysiology
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).
Interventions
DEVICEViewFlex X ICE System
Subjects to undergo cardiac ablation procedure utilizing the ViewFlex X ICE System
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 trial with an active treatment arm or has participated in such a clinical trial within 30 days prior to enrollment that may interfere with this clinical trial without pre-approval from this study Sponsor 2. Implanted mechanical mitral or tricuspid valve replacement 3. Implanted intracardiac device within 30 days 4. Pregnant or nursing 5. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physician assessment of the ability to navigate the ViewFlex X SE catheter and adequately visualize major cardiac anatomic structures. | During the procedure |
| Physician assessment of the ability to use anatomic ICE markers and ICE geometry as a reference during mapping and ablation procedures. | during the procedure |
| Rate of device- or procedure-related serious adverse events that occur through patient discharge. | during the procedure and periprocedurally |
Countries
United States
Contacts
CONTACTBen Gansemer, PhD
CONTACTAmber Miller, PhD
STUDY_DIRECTORKristin Ruffner, PhD
Abbott
Outcome results
None listed