ViewFlex X ICE First-in-Human Study

Launched by ABBOTT MEDICAL DEVICES · Jan 10, 2025

Keywords

ClinConnect Summary

The ViewFlex X ICE First-in-Human Study is a clinical trial designed to test a new medical device called the ViewFlex X ICE Catheter, which is used to help doctors see and treat heart rhythm problems, known as cardiac arrhythmias. This study aims to see how well this device works when paired with a special ultrasound console and an advanced mapping system. The trial is currently recruiting participants who are at least 18 years old and are planning to have a procedure that involves the use of this imaging technique.

To join the study, participants need to be able to give their consent and must not have certain medical conditions, like having a recent heart device implanted or being pregnant. If eligible, participants can expect to undergo standard procedures while the new device is tested, and they will be monitored closely throughout the study. This trial is an important step in understanding how this new technology may improve care for patients with heart rhythm issues.

Gender

ALL

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 investigation.
• • 2. Implanted left atrial appendage occluder
• • 3. Implanted mechanical mitral or tricuspid valve replacement
• • 4. Implanted intracardiac device within 30 days
• • 5. Pregnant or nursing
• • 6. 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.