Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics: A Multicenter Study

What this Trial Is About

Researchers are evaluating imaging methods used after left atrial appendage closure (LAAC) with the Watchman FLX device to monitor device characteristics. The study compares the current standard method, transesophageal echocardiogram (TEE), which involves inserting an ultrasound probe into the esophagus under sedation, with cardiac computerized tomography angiography (cardiac CTA), a non-invasive scan using X-rays and contrast dye. This research aims to determine how well cardiac CTA performs compared to TEE for detecting device-related issues such as leaks and thrombosis. Participants will undergo both TEE and cardiac CTA on the same day, 90 days after their LAAC procedure. TEE will be done using a 3D probe capturing multiple views of the heart and device, while cardiac CTA will be performed with ECG gating and contrast timed for optimal imaging of the left atrium and device. The study involves one group of patients who have received the Watchman FLX device as part of their treatment. Participants will be followed for one year starting from their LAAC procedure day. They will have the standard TEE and cardiac CTA scans at 90 days post-procedure, a routine follow-up visit, and a brief phone check-in at one year. Researchers will measure device-related outcomes such as leaks and thrombus presence using both imaging methods, as well as device size and compression. Safety events will also be tracked shortly after the procedure.

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