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NCT02213666 · ClinicalTrials.gov registry record
Comparison of Intracardiac Echocardiography and Transesophageal Echocardiography
A clinical trial of Atrial Fibrillation and Atrial Flutter, sponsored by Elad Anter.
- Completed
- Registry status
- 72
- Enrollment target
- 1
- Study location
NCT02213666: Completed study of Atrial Fibrillation and Atrial Flutter, sponsored by Elad Anter.
NCT02213666 is a study of Atrial Fibrillation and Atrial Flutter that has completed, run by Elad Anter. The registered enrollment target is 72 participants, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02213666, a study of Atrial Fibrillation and Atrial Flutter, has completed, sponsored by Elad Anter.
- COMPLETED
- Registry status
- 72 participants
- Enrollment target
- 1
- Study location
Study 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 di
Primary Outcome
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 abse
Conditions Studied
Interventions
- DEVICE Intracardiac Imaging
Study Locations (1)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-05 |
What the finished NCT02213666 record still lists
NCT02213666 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which Intracardiac Imaging is the first listed.
NCT02213666 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02213666 about?
NCT02213666 is a clinical study titled "Comparison of Intracardiac Echocardiography and Transesophageal Echocardiography". 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 modalit...
What is the current status of trial NCT02213666?
This trial is currently completed. The enrollment target is 72 participants. The study started on 2012-01. Estimated completion is 2014-05.
What conditions does trial NCT02213666 study?
This clinical trial studies the following conditions: Atrial Fibrillation, Atrial Flutter.
What interventions are being tested in trial NCT02213666?
The interventions under investigation include: Intracardiac Imaging (DEVICE).
Who is sponsoring clinical trial NCT02213666?
This trial is sponsored by Elad Anter, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02213666 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02213666's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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