Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06523166

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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