Cardiac CT versus TEE for imaging the Watchman FLX left atrial appendage occluder
Official title: Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics: A Multicenter Study
Run by University Hospitals Cleveland Medical Center · NCT06523166 · Data updated 2026-11-12
This test sees if cardiac CT can be used instead of TEE to check the Watchman FLX device in patients 90 days after left atrial appendage closure.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 320 (estimated) |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 5 sites (Los Angeles, California and 4 other locations) |
| Status | Recruiting |
| Started | March 27, 2026 |
| Main results expected | January 1, 2027 |
| Study ends | January 1, 2027 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT06523166 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (>18 years) who undergo left atrial appendage closure with the Watchman FLX device, have eGFR ≥ 30 mL/min/1.73 m2, and have no contrast allergy are ideal candidates.
✕Probably not a fit
Patients with eGFR < 30 mL/min/1.73 m2, a history of iodinated contrast allergy, pregnancy, or inability to undergo CT imaging are unlikely to benefit from the cardiac CT option.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults who receive a Watchman FLX left atrial appendage occluder will undergo both a transesophageal echocardiogram (TEE) and a cardiac CT angiography (CTA) on the same day about 90 days after their implant. The study compares findings such as peri-device leak and device-related thrombosis between the two imaging modalities. Eligible participants must be over 18, have eGFR ≥ 30 mL/min/1.73 m2, and have no contrast allergy, with pregnant and non-English-speaking individuals excluded. Imaging is performed at participating U.S. hospitals using standard TEE and cardiac CTA protocols to directly compare device characteristics.
Why it matters
Potential benefit: If cardiac CT performs as well as TEE, patients could have a noninvasive alternative that avoids sedation and an esophageal probe for 90-day device surveillance.
How similar studies have gone: Prior research has shown cardiac CTA can often detect peri-device leaks and thrombus for LAA occluders, though TEE remains the standard surveillance tool at many centers.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects \>18 years old planned to undergo LAAC * eGFR ≥ 30 mL/min per 1.73 m2 Exclusion Criteria: * 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's running
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Sanger Heart & Vascular Institute- Atrium Health
Charlotte, North Carolina, United States Recruiting -
Cedars Sinai
Los Angeles, California, United States Not yet recruiting -
St. Francis Hospital and Catholic Health
Roslyn, New York, United States Not yet recruiting -
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States Not yet recruiting -
Ohio State University Medical Center
Columbus, Ohio, United States Not yet recruiting
Study contacts
- Principal investigator: Steven Filby, MD — University Hospitals Cleveland Medical Center
- Study coordinator: Amy McKnight, RN, BSN, BCCV
- Email: Amy.McKnight@UHhospitals.org
- Phone: 216-983-4896
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.