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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Aug 31, 2026 → Jan 1, 2027
See other at-risk trials from University Hospitals Cleveland Medical Center

Record History

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  1. Primary endpoints: details revised at 4 of 4 entries Show 4 more changesShow less
    • Primary and study completion pushed from Aug 31, 2026 to Jan 1, 2027
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Site details revised at 1 of 5 sites
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 1, 2025 to Mar 27, 2026
    • Primary and study completion dates: Mar 31, 2026 to Aug 31, 2026
    • Site details revised at 5 of 5 sites
    v7
  3. Start date: Aug 1, 2025 to Dec 1, 2025
    • Primary and study completion dates: Oct 31, 2025 to Mar 31, 2026
    v6
  4. Start date: Jun 1, 2025 to Aug 1, 2025v5
  5. Start date: Feb 1, 2025 to Jun 1, 2025
    • Primary and study completion dates: May 31, 2025 to Oct 31, 2025
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Lead sponsor: Steven Filby, MD to University Hospitals Cleveland Medical Center
    • Start date: Nov 1, 2024 to Feb 1, 2025
    • Primary and study completion dates: Jan 31, 2025 to May 31, 2025
    v3
  2. Start date: Sep 1, 2024 to Nov 1, 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06523166
Lead Sponsor University Hospitals Cleveland Medical Center
Collaborators: Boston Scientific Corporation
Conditions
(from sponsor)		 Device Related Thrombosis, Peri-device Leak
Enrollment 320 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov