ViewFlex X ICE First-in-Human Study
Purpose
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).
Condition
- Cardiac Arrhythmias
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Cohort 1 | Single Arm group to undergo a cardiac ablation procedure utilizing the ViewFlex X ICE System |
|
| Cohort 2 | Single Arm group to undergo a cardiac ablation procedure utilizing the ViewFlex X ICE System |
|
| Cohort 3 | Single Arm group to undergo a cardiac ablation procedure utilizing the ViewFlex X ICE System |
|
Recruiting Locations
Jonesboro, Arkansas 72401
La Jolla, California 92037
Kansas City, Missouri 64132
New York, New York 10016
Philadelphia, Pennsylvania 19104
Charleston, South Carolina 29425
Houston, Texas 77030
More Details
- NCT ID
- NCT06772493
- Status
- Recruiting
- Sponsor
- Abbott Medical Devices