Clinical trial NCT06523166: Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics
Official title: Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics: A Multicenter Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Device Related Thrombosis
Peri-device Leak
Keywords: Watchman FLX
Left atrial appendage (LAA)
Transesophageal echocardiography (TEE)
Cardiac CTA
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2024-07-26
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: LAA patency percentage associated with peri device leak (PDL) as measured by CT scan/TEE
timeFrame: 3 months post procedure
measure: LAA patency percentage associated with intra device leak (IDL) as measured by CT scan/TEE.
timeFrame: 3 months post procedure
measure: LAA patency percentage associated with a combination of both PDL and IDL as measured by CT scan/TEE.
timeFrame: 3 months post procedure
measure: Number of detected device-related thrombus (DRT) as measured by CT scan/TEE.
timeFrame: 3 months
Secondary outcomes:
measure: Average size of device measured in millimeters (mm)
timeFrame: 3 months
measure: Percent of compression as measured by CT scan/TEE
timeFrame: 3 months
measure: Average depth of implant measured in millimeters (mm)
timeFrame: 3 months
measure: Average hypo-attenuated thickening (HAT) measured in millimeters (mm)
timeFrame: 3 months
measure: Number of adverse events as measured by medical record
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai
state: California
city: Roslyn
country: United States
facility: St. Francis Hospital and Catholic Health
state: New York
city: Charlotte
country: United States
facility: Sanger Heart & Vascular Institute- Atrium Health
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Steven Filby, MD
role: PRINCIPAL_INVESTIGATOR
References: