Comparison of Intracardiac Echocardiography and Transesophageal Echocardiography

NCT ID: NCT02213666

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-05-31

Brief Summary

The presence of intracardiac thrombi and their propensity for systemic embolism is a major concern in patients with atrial fibrillation (AF) and atrial flutter (AFL) undergoing cardioversion and ablation procedures. Transesophageal echocardiography (TEE) is the clinical gold standard imaging modality for visualization of the right atrial appendage (RAA) and left atrial appendage (LAA) for detection of thrombi as well as risk factors associated with thrombus formation, including spontaneous echo contrast and low LAA velocity. However, TEE is a moderately invasive procedure that incurs additional risk, cost, and patient discomfort. In addition, thrombus detection via TEE may be ambiguous, and another tool capable of confirming uncertain TEE findings is desirable. This is particularly crucial in cases when adequate LAA imaging cannot be acquired or if TEE is clinically contraindicated, requiring alternative imaging modalities that can visualize these structures.

Phased-array intracardiac echocardiography (ICE) provides high-imaging resolution and is routinely used during atrial fibrillation (AF) ablation procedures for transseptal puncture and periprocedural catheter visualization. A majority of imaging acquired during AF ablation is performed with the ICE catheter in the right atrium (RA). However, these standard views are often unable to provide sufficient visualization of the LAA structure due to the relatively long distance between the ICE catheter and LAA.

Placement of the ICE catheter in the pulmonary artery (PA) provides improved visualization of the LAA over other locations by reducing the anatomic distance between the imaging catheter and structure of interest. Recent retrospective studies have confirmed improved assessment of the LAA with ICE imaging from the PA and equivocal sensitivity and specificity when compared with TEE for evaluation of LAA thrombus. However, these studies did not systematically evaluate the presence of SEC, flow velocity, the LAA dimensions, or the RAA.

Although these studies support the use of ICE imaging from the PA to clarify or confirm TEE findings, a prospective and blinded study evaluating both the LAA and RAA in its entirety is required. We hypothesize that this prospective and blinded study will confirm ICE as non-inferior to TEE in the assessment of LAA and RAA structure and for the detection of thrombi.

Detailed Description

Transesophageal echocardiography (TEE) is the clinical standard for diagnosis of left atrial appendage (LAA) and right atrial appendage (RAA) thrombi before cardioversion or instrumentation of the left atrium during ablation proce- dures.1-5 Occasionally, TEE cannot be performed because of anatomic limitations requiring an alternative imaging strategy to exclude LAA thrombi. Phased-array intracardiac echocardiography (ICE) is routinely used during atrial fibrillation (AF) ablation procedures to guide transseptal puncture and detect complications. The standard position of the transducer is in the right atrium (RA). This allows adequate visualization of the interatrial septum and body of the left atrium (LA) but not of the LAA because of significant physical distance from the transducer. Imaging of the LAA from closer anatomic structures such as the right ventricular outflow tract (RVOT) and pulmonary artery (PA) can improve visualization of the LAA. If ICE provided imaging of the LAA comparable to TEE with a good safety profile, it could potentially serve as an alternative to TEE in patients undergoing catheter ablation. Such an approach could reduce risk, cost, and patient discomfort associated with TEE combined with ICE. In this prospective blinded study, we sought to directly compare the sensitivity and specificity of TEE with ICE for detection of LAA and RAA anatomy and thrombus in patients with atrial tachyarrhythmias undergoing catheter ablation.

Conditions

Atrial Fibrillation; Atrial Flutter

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Intracardiac and Transesophageal Echocardiography

Imaging of the right atrial appendage and left atrial appendage with ICE and TEE

Intracardiac Imaging

Intervention Type: DEVICE

Imaging of the RAA and LAA with ICE and assessment of thrombus.

Interventions

Intracardiac Imaging

Imaging of the RAA and LAA with ICE and assessment of thrombus.

Intervention Type: DEVICE

Other Intervention Names

Siemens AcuNav 8 French Phased Array Intracardiac Ultrasound Catheter

Eligibility Criteria

Inclusion Criteria

• Patients able to understand and critically review the informed consent.
• Patients presenting for an AF and/or AFL ablation procedure who have clinical indication for TEE and ICE.

Exclusion Criteria

• Patients in whom placement of an ICE catheter for adequate atrial visualization is technically not feasible.
• Patients requiring urgent cardioversion.
• Patients with a contraindication for TEE
• Inability to give informed consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biosense Webster, Inc.

INDUSTRY

Sponsor Role: collaborator

Elad Anter

OTHER

Sponsor Role: lead

Responsible Party

Elad Anter

Attending Physician, Cardiac Electrophysiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Elad Anter, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Cory M Tschabrunn, CEPS

Role: STUDY_DIRECTOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2011P000387

Identifier Type: -

Identifier Source: org_study_id