Comparison of Intracardiac Echocardiography and Transesophageal Echocardiography

NCT02213666 | Completed Results

• 1 other identifier: 2011P000387
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Atrial Flutter

Keywords

Atrial fibrillation ablation; Intracardiac echocardiography; Thrombus; Left atrial appendage; Right atrial appendage

Outcome Measures

Primary Outcomes (1)

• Intracardiac and Transesophageal Echo Results

  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.

  Time of Clinical Procedure Only (Average 6 hours)

Study Arms (1)

Intracardiac and Transesophageal Echocardiography

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

Device: Intracardiac Imaging

Interventions

Intracardiac Imaging DEVICE

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

Also known as: Siemens AcuNav 8 French Phased Array Intracardiac Ultrasound Catheter

Intracardiac and Transesophageal Echocardiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elad Anter: lead
• Biosense Webster, Inc.: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Thrombosis

Interventions

Cardiac Imaging Techniques

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Limitations and Caveats

This study compared TEE and ICE for visualization of the LAA and RAA in a specific patient population with nonvalvular AF treated with chronic anti-coagulation. The utility of ICE in other patient populations has not been examined.

Results Point of Contact

• Title: Elad Anter, MD
• Organization: Beth Israel Deaconess Medical Center

eanter@bidmc.harvard.edu

617-632-9209

Study Officials

• Elad Anter, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

• Cory M Tschabrunn, CEPS

  Beth Israel Deaconess Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician, Cardiac Electrophysiology

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: August 11, 2014
• Study Start: January 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: May 1, 2014
• Last Updated: May 3, 2017
• Results First Posted: May 3, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)