University Hospitals Cleveland Medical Center
Steven Filby, MD
The current standard of care for patients who underwent left atrial appendage closure (LAAC) is to have follow-up transesophageal echocardiogram (TEE) for device surveillance. TEE is an ultrasound of the heart done by placing a probe in the esophagus under conscious sedation. It does not use contrast but can be cumbersome to patients as it involves placing a probe in the esophagus. Cardiac computerized tomography angiography (cardiac CTA) is a non-invasive imaging modality that involves the use of certain types of x-rays, contrast (dye) and special computers to generate accurate images of the heart. Participants in this study will undergo both TEE and CTA on the same day 90 days after their LAAC procedure. Participants will be in this research study for a period of 1 year, starting from the day of their scheduled LAAC procedure. Participants will undergo a TEE at 90 days after their procedure which is the standard of care imaging study after LAAC. As part of this study, participants will also undergo a cardiac CTA at 90 days as well. Participants will have a routine follow-up visit following device placement as per standard of care as well as a brief phone "check in" at 1 year.
Device Related Thrombosis
Peri-device Leak
Transesophageal echocardiography (TEE)
Cardiac CTA
NA
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 320 participants |
| Masking : | NONE |
| Primary Purpose : | DIAGNOSTIC |
| Official Title : | Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics: A Multicenter Study |
| Actual Study Start Date : | 2025-06-01 |
| Estimated Primary Completion Date : | 2025-10-31 |
| Estimated Study Completion Date : | 2025-10-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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