An interventional study of Transesophageal echocardiography (TEE) and Cardiac CTA in Device Related Thrombosis and Peri-device Leak, sponsored by University Hospitals Cleveland Medical Center. Recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Diagnostic
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.
University Hospitals Cleveland Medical Center is the lead sponsor of 283 studies on the registry; 42 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 29 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who are status post LAAC using the Watchman FLX.
Procedure: Transesophageal echocardiography (TEE) · Procedure: Cardiac CTA
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.
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.
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
Average size of device measured in millimeters (mm)
Time frame: 3 months
Percent of compression as measured by CT scan/TEE
Percent compression is comprised by dividing the device diameter over the device size represented as one single score.
Time frame: 3 months
Average depth of implant measured in millimeters (mm)
Time frame: 3 months
Average hypo-attenuated thickening (HAT) measured in millimeters (mm)
Time frame: 3 months
Number of adverse events as measured by medical record
Adverse events can include respiratory failure requiring intubation or an esophageal perforation from TEE probe insertion or serious contrast related event including anaphylaxis during the CTA or acute renal failure (ARF) requiring dialysis within 7 days of the CTA.
Time frame: Up to 7 days
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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University Hospitals Cleveland Medical Center