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Study identifier: NCT06523166 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics

Condition: Device Related Thrombosis · Peri-device Leak  ·  Sponsor: University Hospitals Cleveland Medical Center

PhaseNA
Planned participants320
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Amy McKnight, RN, BSN, BCCV  ·  216-983-4896  ·  Amy.McKnight@UHhospitals.org

Always discuss trial participation with your own doctor first.

Locations (5)

Cedars SinaiLos Angeles, California, United StatesNot Yet Recruiting
St. Francis Hospital and Catholic HealthRoslyn, New York, United StatesNot Yet Recruiting
Sanger Heart & Vascular Institute- Atrium HealthCharlotte, North Carolina, United StatesRecruiting
University Hospitals Cleveland Medical CenterCleveland, Ohio, United StatesNot Yet Recruiting
Ohio State University Medical CenterColumbus, Ohio, United StatesNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT06523166