Use of 4D-ICE in Conjunction With TEE for Left Atrial Appendage Closure

Kansas City Heart Rhythm Research Foundation

Status: Enrolling

Conditions: Atrial Fibrillation; Stroke

Treatments: Device: Imaging guidance with TEE and ICE for Left atrial appendage closure

Study type: Interventional

Funder types: Other

Identifiers

NCT06061757

KCHRRF_Nuvision ICE_0017

Details and patient eligibility

About

This is a prospective, single center, non-randomized study with two parallel arms intended to study if 4D Intracardiac echocardiography (4D-ICE) (Nuvision, Nuvera TM) will provide better visualization of the anatomical landmarks from the larger imaging volume and provide optimal intra procedural guidance similar to Transesophageal echocardiography (TEE) (GE 6VT-D ULTRASOUND TRANSDUCER) for Left atrial appendage closure (LAAC). The study will enroll approximately 52 subjects and will be followed through 12 months.

Full description

Standard intraprocedural guidance for transcatheter left atrial appendage closure (LAAC) employs a multi-modality integrated approach combining fluoroscopy for guiding the delivery system, and transesophageal echocardiography (TEE) for intracardiac characterization to guide device selection and monitor procedural complications. Successful implantation of the device is confirmed with contrast-enhanced fluoroscopy and color doppler flow imaging on TEE. TEE is the current gold standard for procedural guidance but requires general anesthesia (GA) to avoid patient motion and discomfort during the procedure. General anesthesia, however, is associated with pulmonary complications and patient discomfort due to endotracheal intubation. Intraprocedural LAAC guidance under local anesthesia or conscious sedation might help mitigate these GA-related disadvantages and has motivated multiple clinical studies, establishing intracardiac echocardiography (ICE) as a safe and feasible alternative to TEE.

The new generation of NuVision ICE catheter offers a larger imaging volume of 90° x 90° with multiplanar reformatted (MPR) echo views for better visualization of anatomical landmarks and procedural guidance and aid in sizing of the device. This has a potential to improve outcomes and reduce procedure times while lowering healthcare costs.

In this study, Role of NuVision Intracardiac Echocardiographic (ICE) catheter with Tranesopheal echocardiography (TEE) in predicting intra-procedural outcomes and success of implantation in patients undergoing left atrial appendage occlusion will be assessed.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male/Females
• Age:18-80 years
• History of Atrial Fibrillation/Atrial flutter
• Will have endocardial Left Atrial Appendage Closure (LAAC) with an Amplatzer Amulet or WATCHMAN FLX device

Exclusion criteria

• Inability or unwillingness of an individual to give written informed consent
• Patient not following with our practice after the procedure
• Complex anatomy for endocardial LAAC
• Thrombus in LAA
• Patients with pericardial effusion in pre-op TEE/CCTA
• Patients currently pregnant (Serum beta HCG completed when labs obtained for the procedure are completed)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Arm 1 - TEE Primary imaging guidance

Experimental group

Description:

TEE is the primary imaging guidance with 4D ICE is the secondary

Treatment:

Device: Imaging guidance with TEE and ICE for Left atrial appendage closure

Arm 2 - ICE Primary Imaging Guidance

Experimental group

Description:

4D ICE is the primary imaging guidance and TEE is the secondary

Treatment:

Device: Imaging guidance with TEE and ICE for Left atrial appendage closure