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โ† Trials
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Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics

RecruitingNAAges 18 Years - anyAllUniversity Hospitals Cleveland Medical Center
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In plain words

What the trial is, and whether it could suit you

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 pro

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Subjects \>18 years old planned to undergo LAAC * eGFR โ‰ฅ 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
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What it tests

  • Transesophageal echocardiography (TEE)
  • Cardiac CTA
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Where

5 sites
Cedars Sinai
Los Angeles, United States
St. Francis Hospital and Catholic Health
Roslyn, United States
Sanger Heart & Vascular Institute- Atrium Health
Charlotte, United States
University Hospitals Cleveland Medical Center
Cleveland, United States
Ohio State University Medical Center
Columbus, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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