Comparison of Intracardiac Echocardiography and Transesophageal Echocardiography

Atrial Fibrillation Clinical Trial

— ICE-TEE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02213666
• Other study ID #: 2011P000387
• Status: Completed
• Phase: Phase 4
• First received: July 15, 2014
• Last updated: August 7, 2014
• Start date: January 2012
• Est. completion date: May 2014

Study information

• Verified date: August 2014
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Intervention

Device:
• Intracardiac Imaging
Imaging of the RAA and LAA with ICE and assessment of thrombus.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Elad Anter	Biosense Webster, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of RAA and LAA intracardiac thrombi	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.	Time of Clinical Procedure Only (Enrollment)	Yes
Secondary	Doppler flow velocity of RAA and LAA	Doppler flow velocity of the right atrial appendage (RAA) and left atrial appendage (LAA) will be measured with the Siemens AcuNav Ultrasound catheter. This is then recorded for offline assessment and comparison to standard of care measurements obtained with Transesophageal Echocardiogram (TEE). This is obtained at the time of the clinical procedure and analyzed offline. There is no follow-up data collected.	Time of Clinical Procedure Only (Enrollment)	No
Secondary	LAA and RAA anatomical dimensions	The anatomical width (centimeters) length (centimeters), and area (centimeters squared) of the right atrial appendage (RAA) and left atrial appendage (LAA) will be measured with the Siemens AcuNav Ultrasound catheter offline and compared to measurements obtained with Transesophageal Echocardiogram (TEE). There is no follow-up data collected.	Time of Clinical Procedure Only (Enrollment)	No