No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
500 (estimated)
Sponsor
Abbott Medical Devices · Industry
Who this trial is looking for
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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).
Trial Locations
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Status
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 year…
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.
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