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Clinical trialNCT06523166RecruitingInterventional

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

SponsorUniversity Hospitals Cleveland Medical CenterEnrollment320Device Related ThrombosisPeri-device Leak
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

5 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Cedars Sinai

    Los Angeles, California, United States

    John Friedman, MD
    Not, yet, recruiting
  • St. Francis Hospital and Catholic Health

    Roslyn, New York, United States

    Omar Khlaique, MD
    Not, yet, recruiting
  • Sanger Heart & Vascular Institute- Atrium Health

    Charlotte, North Carolina, United States

    Markus Scherer, MD
    Recruiting
  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, United States

    Steven Filby, MD
    Not, yet, recruiting
  • Ohio State University Medical Center

    Columbus, Ohio, United States

    Mahmoud Houmssee, MD
    Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
27 Mar 2026
Primary completion
31 Aug 2026
Completion
31 Aug 2026
Last update posted
7 Apr 2026
Registered enrollment
320
Registry id
NCT06523166

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.