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

NANot yet recruitingINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

December 1, 2025

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
Device Related ThrombosisPeri-device Leak
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.

Trial Locations (5)

11576

St. Francis Hospital and Catholic Health, Roslyn

28277

Sanger Heart & Vascular Institute- Atrium Health, Charlotte

43210

Ohio State University Medical Center, Columbus

44106

University Hospitals Cleveland Medical Center, Cleveland

90048

Cedars Sinai, Los Angeles

Sponsors
All Listed Sponsors
collaborator

Boston Scientific Corporation

INDUSTRY

lead

University Hospitals Cleveland Medical Center

OTHER