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

Recruiting N/A Interventional Study
Device Related Thrombosis Peri-device Leak
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
320 (estimated)
Sponsor
University Hospitals Cleveland Medical Center · Other
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About This Trial
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 compute…
Trial Locations
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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
Contacts

Amy McKnight, RN, BSN, BCCV

216-983-4896

Amy.McKnight@UHhospitals.org

CONTACT