Actively Recruiting
Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics
Led by University Hospitals Cleveland Medical Center · Updated on 2026-04-07
320
Participants Needed
5
Research Sites
22 weeks
Total Duration
On this page
Sponsors
U
University Hospitals Cleveland Medical Center
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects older than 18 years planned to undergo left atrial appendage closure (LAAC)
- Estimated glomerular filtration rate (eGFR) of at least 30 mL/min per 1.73 m2
You will not qualify if you...
- Subjects younger than 18 years
- Non-English speaking subjects
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min per 1.73 m2
- History of contrast dye allergy
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Cedars Sinai
Los Angeles, California, United States, 90048
Not Yet Recruiting
2
St. Francis Hospital and Catholic Health
Roslyn, New York, United States, 11576
Not Yet Recruiting
3
Sanger Heart & Vascular Institute- Atrium Health
Charlotte, North Carolina, United States, 28277
Actively Recruiting
4
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
5
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Not Yet Recruiting
Research Team
A
Amy McKnight, RN, BSN, BCCV
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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