An observational study in Atrial Fibrillation and Atrial Flutter, sponsored by Elad Anter. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-03.
Sponsored by Elad Anter · Observational
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.
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 72 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →This is the only study on the registry with Elad Anter as lead sponsor.
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Patients with drug-refractory, symptomatic, paroxysmal or persistent atrial fibrillation or atrial flutter requiring a clinical indicated ablation procedure.
Exclusion Criteria:
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.
Also known as: Siemens AcuNav 8 French Phased Array Intracardiac Ultrasound Catheter
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 frame: Time of Clinical Procedure Only (Average 6 hours)
Patients were interviewed in the pre-procedure room on the day of the planned procedure after consenting for the planned clinical procedure. A Co-Investigator introduced and discussed the study with the patient in detail, provided the consent form to review and addressed any questions.
| Milestone | Intracardiac and Transesophageal Echocardiography |
|---|---|
| Started | 72 |
| Completed | 71 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
| participants | Enrolled Patients |
|---|---|
| Intracardiac Echo Completed | 71 |
| TEE Completed | 69 |
| Total Cases of Definite Thrombi Identified | 4 |
| TEE Diagnostic in Identification of Thrombi | 1 |
| ICE Diagnostic in Identification of Thrombi | 4 |
Collected over During enrollment, the clinical ablation procedure, while in the hospital.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Enrolled Patients | — | 0/71 (0%) | 2/71 (2.8%) |
| Event | Enrolled Patients |
|---|---|
| Oropharyngeal bleeding from TEESurgical and medical procedures | 2/71 |
Patients enrolled into study that underwent ICE and TEE imaging.
| Age, Continuous(years) | Enrolled Patients |
|---|---|
| Mean | 61 ± 11 |
| Sex: Female, Male(Participants) | Enrolled Patients |
|---|---|
| Female | 19 |
| Male | 53 |
| Region of Enrollment(participants) | Enrolled Patients |
|---|---|
| United States | 72 |
Plan to share: No
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