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

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation; Stroke
• Interventions: Device: Imaging guidance with TEE and ICE for Left atrial appendage closure

• Registration Number: NCT06061757
• Lead Sponsor: Kansas City Heart Rhythm Research Foundation

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2023-05-10
• Study First Submitted: 2023-09-11
• Study First Submitted QC: 2023-09-25
• Study First Posted: 2023-09-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-16
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 - TEE Primary imaging guidance	Imaging guidance with TEE and ICE for Left atrial appendage closure	TEE is the primary imaging guidance with 4D ICE is the secondary
Arm 2 - ICE Primary Imaging Guidance	Imaging guidance with TEE and ICE for Left atrial appendage closure	4D ICE is the primary imaging guidance and TEE is the secondary

Primary Outcome Measures

Name	Time	Method
Success of Implantation of Left Atrial Appendage Closure (LAAC) device	1 Day	Success of Implantation of Amulet or Watchman FLX device

Secondary Outcome Measures

Name	Time	Method
Location of the leaks	1 Day	Location of the leaks will be identified
Intraprocedural measurements	1 Day	Procedural duration, Fluoroscopic time
Intraprocedural measurements - LAA device size	1 Day	LAA device size will be measured based on the LAA size

Trial Locations

Locations (1)

Kansas City Heart Rhythm Institute - Roe Clinic; 🇺🇸 Overland Park, Kansas, United States