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Comparison of Intracardiac Echocardiography and Transesophageal Echocardiography (ICE-TEE)

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ClinicalTrials.gov Identifier: NCT02213666
Recruitment Status : Completed
First Posted : August 11, 2014
Results First Posted : May 3, 2017
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Elad Anter, Beth Israel Deaconess Medical Center

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.


Condition or disease Intervention/treatment
Atrial Fibrillation Atrial Flutter Device: Intracardiac Imaging

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.

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Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Intracardiac Echocardiography and Transesophageal Echocardiography for Imaging of the Left Atrial Appendage and Right Atrial Appendage in Patients With Atrial Fibrillation
Study Start Date : January 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Intracardiac and Transesophageal Echocardiography
Imaging of the right atrial appendage and left atrial appendage with ICE and TEE
Device: Intracardiac Imaging
Imaging of the RAA and LAA with ICE and assessment of thrombus.
Other Name: Siemens AcuNav 8 French Phased Array Intracardiac Ultrasound Catheter




Primary Outcome Measures :
  1. Intracardiac and Transesophageal Echo Results [ Time Frame: Time of Clinical Procedure Only (Average 6 hours) ]
    The right atrial appendage (RAA) and left atrial appendage (LAA) will be assessed for the presence or absence of intracardiac thrombi with the Siemens AcuNav Ultrasound catheter. This is also performed with the standard of care modality, transesophageal echocardiography (TEE) with both operators blinded to the opposing imaging modality. The presence of LAA thrombi requires cancellation of the clinical procedure. After a determination has been made by both operators regarding the presence or absence of thrombi will investigators be unblinded to the opposing imaging modality result. If intracardiac thrombi was detected, the procedure was cancelled according to standard clinical guidelines and practice. There is no follow-up data collected. Participants were followed during enrollment and the clinical ablation procedure which is an average of a 6 hour period.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with drug-refractory, symptomatic, paroxysmal or persistent atrial fibrillation or atrial flutter requiring a clinical indicated ablation procedure.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213666


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Elad Anter
Biosense Webster, Inc.
Investigators
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Principal Investigator: Elad Anter, MD Beth Israel Deaconess Medical Center
Study Director: Cory M Tschabrunn, CEPS Beth Israel Deaconess Medical Center

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Responsible Party: Elad Anter, Attending Physician, Cardiac Electrophysiology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT02213666    
Other Study ID Numbers: 2011P000387
First Posted: August 11, 2014    Key Record Dates
Results First Posted: May 3, 2017
Last Update Posted: May 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Elad Anter, Beth Israel Deaconess Medical Center:
Atrial fibrillation ablation
Intracardiac echocardiography
Thrombus
Left atrial appendage
Right atrial appendage
Additional relevant MeSH terms:
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Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes