NCT06523166 · University Hospitals Cleveland Medical Center
Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics
What this study is about
The current the usual treatment 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.
View original scientific description
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.
Interventions
PROCEDURE
Transesophageal echocardiography (TEE)
TEE will be performed using a 3D probe. TEE images will be acquired at the standard 0, 45, 90, and 135 degree views along with a 3D acquisition encompassing the entire LAA, device, left pulmonary vein and lateral mitral annular landmarks.
PROCEDURE
Cardiac CTA
Cardiac CTA will be performed with ECG gating using systems with ≥ 64 detector rows and with temporal resolution that is at least 175 msec (rotation speed ≤ 350 msec for single source systems). Cardiac CTA images will be acquired for the entire cardiac cycle without ECG phase specific pulsing and with contrast appropriately timed for peak left atrial/arterial phase contrast enhancement. In addition, a targeted end systolic only delayed phase image set (45 seconds after the arterial phase scan and limited to the left atrium and appendage device) will be acquired.
Primary outcome measures
LAA patency percentage associated with peri device leak (PDL) as measured by CT scan/TEE
Time frame: 3 months post procedure
LAA patency percentage associated with intra device leak (IDL) as measured by CT scan/TEE.
Time frame: 3 months post procedure
LAA patency percentage associated with a combination of both PDL and IDL as measured by CT scan/TEE.
Time frame: 3 months post procedure
Number of detected device-related thrombus (DRT) as measured by CT scan/TEE.
Time frame: 3 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects \>18 years old planned to undergo LAAC
- eGFR ≥ 30 mL/min per 1.73 m2
Exclusion criteria
- 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
Where
- Los Angeles, California
- Roslyn, New York
- Charlotte, North Carolina
- Cleveland, Ohio
- Columbus, Ohio
Collaborators
Boston Scientific Corporation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 7, 2026 · Source of record for eligibility and locations