NCT06523166 Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics
| NCT ID | NCT06523166 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospitals Cleveland Medical Center |
| Condition | Device Related Thrombosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 320 participants |
| Start Date | 2026-03-27 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 320 participants in total. It began in 2026-03-27 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Steven Filby, MD
PRINCIPAL INVESTIGATOR
University Hospitals Cleveland Medical Center
Frequently Asked Questions
Who can join the NCT06523166 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Device Related Thrombosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06523166 currently recruiting?
Yes, NCT06523166 is actively recruiting participants. Contact the research team at Amy.McKnight@UHhospitals.org for enrollment information.
Where is the NCT06523166 trial being conducted?
This trial is being conducted at Los Angeles, United States, Roslyn, United States, Charlotte, United States, Cleveland, United States and 1 additional location.
Who is sponsoring the NCT06523166 clinical trial?
NCT06523166 is sponsored by University Hospitals Cleveland Medical Center. The principal investigator is Steven Filby, MD at University Hospitals Cleveland Medical Center. The trial plans to enroll 320 participants.