Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics
NCT Number: NCT06523166
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Device Related Thrombosis|Peri-device Leak
Interventions: PROCEDURE: Transesophageal echocardiography (TEE)|PROCEDURE: Cardiac CTA
Sponsor: Steven Filby, MD
Collaborators: Boston Scientific Corporation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 320
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-01
Completion Date: 2025-01-31
Locations: Cedars Sinai, Los Angeles, California, 90048, United States|St. Francis Hospital and Catholic Health, Roslyn, New York, 11576, United States|Sanger Heart & Vascular Institute- Atrium Health, Charlotte, North Carolina, 28277, United States|University Hospitals Cleveland Medical Center, Cleveland, Ohio, 44106, United States|Ohio State University Medical Center, Columbus, Ohio, 43210, United States

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.

Primary Outcome Measures: LAA patency percentage associated with peri device leak (PDL) as measured by CT scan/TEE, 3 months post procedure|LAA patency percentage associated with intra device leak (IDL) as measured by CT scan/TEE., 3 months post procedure|LAA patency percentage associated with a combination of both PDL and IDL as measured by CT scan/TEE., 3 months post procedure|Number of detected device-related thrombus (DRT) as measured by CT scan/TEE., 3 months
Secondary Outcome Measures: Average size of device measured in millimeters (mm), 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., 3 months|Average depth of implant measured in millimeters (mm), 3 months|Average hypo-attenuated thickening (HAT) measured in millimeters (mm), 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., Up to 7 days