This single-center, prospective, randomized study will evaluate the safety and feasibility of Intracardiac echocardiography (ICE)-guided Left atrial appendage closure (LAAC) when compared to the traditional Transesophageal echocardiography (TEE) approach.
The primary objective of this study is to assess the efficacy and safety of using Intracardiac echocardiography (ICE) to guide implantation of percutaneous left atrial appendage closure (LAAC) devices. Primary endpoints include procedural success following implantation of the left atrial appendage occlusion (LAAO) device. Procedural success specifies that the device should be implanted in the correct position without device related complications and no peri-device leaks \>5 mm on color doppler. Secondary end points include periprocedural complications (such as pericardial effusion/tamponade, stroke, death, vascular complications, and device embolization), procedural characteristics (total duration, fluoroscopy time, contrast volume, Length of hospital stay), cost of hospitalization, in-hospital patient satisfaction, and clinical alterations at 45-day follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
444
Transesophageal echocardiography will be performed under general anesthesia.
Baylor Scott and White Heart Hospital
Plano, Texas, United States
RECRUITINGProcedural success following implantation of the left atrial appendage occlusion (LAAO) device.
Procedural success specifies that the device should be implanted in the correct position measured as: Peri-device leaks greater than 5 milliliters on color doppler (Yes/No)
Time frame: Intra op
Periprocedural complications
Pericardial effusion/tamponade measured as (Yes/No)
Time frame: 45 days after the procedure
Procedural characteristics
Total duration measured as number of minutes.
Time frame: 45 days after the procedure
Patient satisfaction
Patient satisfaction will be assessed in-hospital by a questionnaire addressing anesthesia-related discomfort.
Time frame: 45 days after the procedure
Periprocedural complications
Stroke measured as (Yes/No)
Time frame: 45 days after the procedure
Periprocedural complications
Death measured as (Yes/No)
Time frame: 45 days after the procedure
Procedural characteristics
Fluoroscopy time measured as number of minutes.
Time frame: 45 days after the procedure
Procedural characteristics
Contrast volume measured in milli liters.
Time frame: 45 days after the procedure
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Procedural characteristics
Length of hospital stay measured as number of days.
Time frame: 45 days after the procedure