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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-10

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion

NCT06348394

Left Atrial Appendage Closure

RECRUITING NA

Left Ventricular Volume and Ejection Fraction: Validation of Real Time 3 Dimensional Transesophageal Echocardiography

NCT01734174

3D Transesophageal and Transthoracic Echocardiogram

WITHDRAWN

Foresight Intracardiac Echocardiography (ICE) System

NCT02514876

Atrial Fibrillation

COMPLETED EARLY_PHASE1

Foresight Intracardiac Echocardiography System (ICE)

NCT03239444

Atrial Fibrillation

COMPLETED PHASE1

A Phase 1 Feasbility Study Of Volume Intracardiac Echo In Assessment Of Patients With Structural And Valvular Heart Disease Undergoing Percutaneous Transcatheter Therapy

NCT01669551

Structural and Valvular Heart Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1 - TEE Primary imaging guidance

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

Group Type EXPERIMENTAL

Imaging guidance with TEE and ICE for Left atrial appendage closure

Intervention Type DEVICE

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.

Arm 2 - ICE Primary Imaging Guidance

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

Group Type EXPERIMENTAL

Imaging guidance with TEE and ICE for Left atrial appendage closure

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Imaging guidance with TEE and ICE for Left atrial appendage closure

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No