Status:
NOT_YET_RECRUITING
Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Device Related Thrombosis
Peri-device Leak
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- Subjects \>18 years old planned to undergo LAAC
- eGFR ≥ 30 mL/min per 1.73 m2
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT06523166
Start Date
December 1 2025
End Date
March 31 2026
Last Update
October 15 2025
Active Locations (5)
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1
Cedars Sinai
Los Angeles, California, United States, 90048
2
St. Francis Hospital and Catholic Health
Roslyn, New York, United States, 11576
3
Sanger Heart & Vascular Institute- Atrium Health
Charlotte, North Carolina, United States, 28277
4
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106