Comparing Cardiac CT and TEE for Watchman FLX Device
This study is comparing two ways to check on your Watchman FLX device after it's been implanted: Transesophageal echocardiography (TEE) and Cardiac Computed Tomography Angiography (Cardiac CTA). TEE is a standard ultrasound where a probe goes down your throat, while Cardiac CTA uses X-rays and a special dye. The study wants to see how well each method finds leaks around or through your device. You can join if you are over 18, are planning to have a left atrial appendage closure (LAAC) procedure, and have healthy kidney function (eGFR of 30 mL/min or higher). The study aims to determine which method is better at detecting these leaks three months after your procedure. The current recruitment status is unclear.
- Study design
- This is an interventional study planning to enroll 320 participants. It directly compares two imaging procedures: Transesophageal echocardiography (TEE) and Cardiac CTA.
- What's involved
- You would undergo both a TEE and a Cardiac CTA on the same day, 90 days after your LAAC procedure.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for at least 3 months after your LAAC procedure for the primary endpoints.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics
At a glance
Conditions
NCT06523166
Where you'd take part
This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Cedars Sinai
Los Angeles, Californiastudy coordinator listed
Not yet recruiting
Ohio State University Medical Center
Columbus, Ohiostudy coordinator listed
Not yet recruiting
Sanger Heart & Vascular Institute- Atrium Health
Charlotte, North Carolinastudy coordinator listed
Recruiting
St. Francis Hospital and Catholic Health
Roslyn, New Yorkstudy coordinator listed
Not yet recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohiostudy coordinator listed
Not yet recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Steven Filby, MD · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- LAA patency percentage associated with peri device leak (PDL) as measured by CT scan/TEE3 months post procedure
- LAA patency percentage associated with intra device leak (IDL) as measured by CT scan/TEE.3 months post procedure
- LAA patency percentage associated with a combination of both PDL and IDL as measured by CT scan/TEE.3 months post procedure
- Number of detected device-related thrombus (DRT) as measured by CT scan/TEE.3 months