Evaluating a new cardiac imaging system for arrhythmias

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• St. Bernards Medical Center
  Jonesboro, Arkansas, United States Recruiting
• University of California, San Diego
  La Jolla, California, United States Recruiting
• Ascension St. Vincent's Riverside
  Jacksonville, Florida, 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

Study contacts

• Study coordinator: Ben Gansemer, PhD
• Email: benjamin.gansemer@abbott.com
• Phone: 9527152719

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.