Cardiac CT versus TEE for imaging the Watchman FLX left atrial appendage occluder
Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics: A Multicenter Study
NA · University Hospitals Cleveland Medical Center · NCT06523166
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospitals Cleveland Medical Center (other) |
| Locations | 5 sites (Los Angeles, California and 4 other locations) |
| Trial ID | NCT06523166 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Los Angeles, California and 4 other locations
- Cedars Sinai — Los Angeles, California, United States (NOT_YET_RECRUITING)
- St. Francis Hospital and Catholic Health — Roslyn, New York, United States (NOT_YET_RECRUITING)
- Sanger Heart & Vascular Institute- Atrium Health — Charlotte, North Carolina, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Device Related Thrombosis, Peri-device Leak, Watchman FLX, Left atrial appendage, Transesophageal echocardiography, Cardiac CTA