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

Study Overview
=================
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.

Official Title
-----------------
Use of 4D Intracardiac Echocardiography (4D-ICE) in Conjunction With Transesophageal Echocardiography (TEE) for Left Atrial Appendage Closure (LAAC)

Conditions
-----------------
Atrial Fibrillation, Stroke

Intervention / Treatment
-----------------
* Device: Imaging guidance with TEE and ICE for Left atrial appendage closure


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 - TEE Primary imaging guidance<br>TEE is the primary imaging guidance with 4D ICE is the secondary | Device: Imaging guidance with TEE and ICE for Left atrial appendage closure<br>* The occluder size for both LAAC devices will be selected based on the maximal diameter of the LAA orifice following the manufacturer guidelines and using the maximal length of the LAA measured on Echocardiogram. Intraprocedural measurements of the LAA width and depth were acquired on both ICE and TEE per protocol. Both ICE and TEE will be used to assess for any procedural complications prior to insertion of the device delivery sheath.<br>|
| Experimental: Arm 2 - ICE Primary Imaging Guidance<br>4D ICE is the primary imaging guidance and TEE is the secondary | Device: Imaging guidance with TEE and ICE for Left atrial appendage closure<br>* The occluder size for both LAAC devices will be selected based on the maximal diameter of the LAA orifice following the manufacturer guidelines and using the maximal length of the LAA measured on Echocardiogram. Intraprocedural measurements of the LAA width and depth were acquired on both ICE and TEE per protocol. Both ICE and TEE will be used to assess for any procedural complications prior to insertion of the device delivery sheath.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of Implantation of Left Atrial Appendage Closure (LAAC) device | Success of Implantation of Amulet or Watchman FLX device | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraprocedural measurements | Transeptal access view, LAA thrombus, Stability of the device, Peri-device leaks, Device Repositioning, Clarity of mitral valve or pulmonary vein impingement will be noted as Yes/No from Echocardiogram | 1 Day | 
| Intraprocedural measurements | LAA size in different sites will be noted from Echocardiograms | 1 Day | 
| Intraprocedural measurements - LAA device size | LAA device size will be measured based on the LAA size | 1 Day | 
| Location of the leaks | Location of the leaks will be identified | 1 Day | 
| Intraprocedural measurements | Procedural duration, Fluoroscopic time | 1 Day |