| NCT ID | NCT06772493 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abbott Medical Devices |
| Condition | Cardiac Arrhythmias |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-12-16 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2024-12-16 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Kristin Ruffner, PhD
STUDY DIRECTOR
Abbott
Frequently Asked Questions
Who can join the NCT06772493 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Arrhythmias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06772493 currently recruiting?
Yes, NCT06772493 is actively recruiting participants. Contact the research team at benjamin.gansemer@abbott.com for enrollment information.
Where is the NCT06772493 trial being conducted?
This trial is being conducted at Jonesboro, United States, La Jolla, United States, Jacksonville, United States, Kansas City, United States and 4 additional locations.
Who is sponsoring the NCT06772493 clinical trial?
NCT06772493 is sponsored by Abbott Medical Devices. The principal investigator is Kristin Ruffner, PhD at Abbott. The trial plans to enroll 500 participants.