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NCT06523166NARecruiting

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

University Hospitals Cleveland Medical Center

Start Date

3/27/2026

Completion Date

8/31/2026

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

Age Range: 18 years to No maximum

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

Interventions

PROCEDURE

Transesophageal echocardiography (TEE)

PROCEDURE

Cardiac CTA

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Conditions

Device Related ThrombosisPeri-device Leak

Locations

Cedars Sinai

Los Angeles, California 90048

United States

St. Francis Hospital and Catholic Health

Roslyn, New York 11576

United States

Sanger Heart & Vascular Institute- Atrium Health

Charlotte, North Carolina 28277

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

Ohio State University Medical Center

Columbus, Ohio 43210

United States