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

Recruiting now · Not applicable

Conditions studied: Device Related Thrombosis, Peri-device Leak

In brief

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.

Key facts

Study ID

NCT06523166

Run by

University Hospitals Cleveland Medical Center

People needed

320

Starts

2026-03-27

Expected to finish

2026-08-31

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects >18 years old planned to undergo LAAC
• eGFR ≥ 30 mL/min per 1.73 m2

You may not qualify if…

• Subjects below the age of 18
• non-English speaking subjects
• eGFR < 30 mL/min per 1.73 m2
• Subjects with history of contrast allergy
• Pregnant women

Where it is running

• Sanger Heart & Vascular Institute- Atrium Health — Charlotte, North Carolina, United States (enrolling)
• Cedars Sinai — Los Angeles, California, United States
• St. Francis Hospital and Catholic Health — Roslyn, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.