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.
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