Recruiting

TEE & CTA

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT06523166

Conditions

Device Related Thrombosis

Peri-device Leak

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transesophageal echocardiography (TEE)

Cardiac CTA

Study Details

Brief summary:

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

Device Related Thrombosis

Peri-device Leak

Study ID

NCT06523166

Start date

Mar 27, 2026

Status verified date

Mar, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

320 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Left Atrial Appendage Occlusion (LAAC) with Watchman FLX.

Patients who are status post LAAC using the Watchman FLX.

Interventions

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.

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Amy McKnight, RN, BSN, BCCV

216-983-4896Amy.McKnight@UHhospitals.org

Locations

Sanger Heart & Vascular Institute- Atrium Health

Recruiting

Charlotte, North Carolina, United States, 28277

Contacts

Dana Amaro, MSN, RN

704-355-4692Dana.Amaro@atriumhealth.org

Principal Investigator:

Markus Scherer, MD

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Apr 7, 2026

Last verified

Mar, 2026

Keywords

  • Watchman FLX
  • Left atrial appendage (LAA)
  • Transesophageal echocardiography (TEE)
  • Cardiac CTA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-04-07.