CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 72 enrolled
Drug / intervention
Intracardiac Imagingdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02213666
NCT02213666N/ACompleted

Comparison of Intracardiac Echocardiography and Transesophageal Echocardiography for Imaging of the Left Atrial Appendage and Right Atrial Appendage in Patients With Atrial Fibrillation

Elad Anter·observational·Posted Aug 11, 2014·Updated May 3, 2017

In Brief

An observational study evaluating Intracardiac Imaging for Atrial Fibrillation and Atrial Flutter. Completed, enrolled 72 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 11, 2014
Enrollment StartJan 1, 2012
Primary CompletionSep 1, 2013
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.9 years ago

Interventions

Intracardiac Imagingdevice

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