Evaluating a new cardiac imaging system for arrhythmias
ViewFlex X ICE First-in-Human Study
This study is testing a new heart imaging system to see if it helps patients with arrhythmias during certain heart procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbott Medical Devices Industry-sponsored |
| Locations | 7 sites (Jonesboro, Arkansas and 6 other locations) |
| Trial ID | NCT06772493 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the performance of the modified ViewFlex X ICE Catheter and its integration with the EnSite X EP System during electrophysiology procedures. It is a first-in-human trial that focuses on patients undergoing procedures that require intracardiac echocardiography (ICE). The study will collect data on the safety and effectiveness of the ViewFlex X ICE System in real-world clinical settings. Participants will be monitored for their ability to provide informed consent and meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for an electrophysiology procedure that utilizes ICE.
Not a fit: Patients with certain implanted devices or those currently participating in other clinical investigations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy and safety of cardiac procedures for patients with arrhythmias.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving cardiac imaging techniques.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jonesboro, Arkansas and 6 other locations
- St. Bernards Medical Center — Jonesboro, Arkansas, United States (Recruiting)
- University of California, San Diego — La Jolla, California, United States (Recruiting)
- Research Medical Center — Kansas City, Missouri, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Houston Methodist Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Ben Gansemer, PhD
- Email: benjamin.gansemer@abbott.com
- Phone: 9527152719
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.