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This is a 2- component, single center study, witch aims to evaluate the efficacy of multisite intracardiac echocardiography (mICE) imaging of left atrial appendage (LAA) and in detecting thrombus located in LAA as compared to transesophageal echocardiography (TEE). The study group will consist of patients eligible for atrial fibrillation (AF) ablation procedure (Component I) or cardioversion (Component II).
First component will enroll 100 patients; these patients will undergo clinically indicated TEE & cardiac catheterization procedures with ICE(AF ablation). Second component will enroll 15-20 patients with AF or atrial flutter in whom a thrombus in LAA was detected by TEE prior to electrical cardioversion. The ICE probe will be located in multiple positions in the right atrium (RA), coronary sinus (CS), pulmonary artery (PA), right ventricular outflow tract (RVOT) and esophagus. This will enable the investigators to compare sensitivity and specificity of mICE and TEE.
This study will examine two hypotheses in AF patients undergoing invasive cardiac procedures:
Hypothesis 1: That ICE has comparable efficacy to TEE in visualization of LAA from multiple positions (RA,CS,PA,RVOT and esophagus ). This will be evaluated during the component I of the study.
Hypothesis 2: That ICE can identify low risk patients, CHADS Score < 2,0 in whom immediate cardioversion during the procedure is as safe as based on conventional strategy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-Cardiac Echocardiography guided atrial fibrillation ablation | Device | 8-F or 10-F phase array ICE-probe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Predictive value of ICE compared to TEE in visualisation of morphology and thrombus in LAA. | Predictive value of ICE compared to TEE in visualization of morphology (area and volume of LAA) and function of LAA (emptying velocity and ejection fraction of LAA) - offline analyses will be conducted. Quality of LAA imaging will be assessed using 5-grade scale, and compared to that obtained by TEE. Grade 0 means unacceptable quality wheras grade 5 means exellent view of LAA. Exclusion of existence of thrombus in LAA by mICE will enable electrical cardioversion of AF during AF ablation procedure. That will by assessed using binary scale - YES or NO. | intraoperative - up to six hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piotr Kulakowski, Prof. | Contact | 0048228105030 | kulak@kkcmkp.pl | |
| Sebastian M Stec, PhD | Contact | 0048512221279 | smstec@wp.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Grenadierow 51/59 | Recruiting | Warsaw | 04 073 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24243787 | Derived | Baran J, Stec S, Pilichowska-Paszkiet E, Zaborska B, Sikora-Frac M, Krynski T, Michalowska I, Lopatka R, Kulakowski P. Intracardiac echocardiography for detection of thrombus in the left atrial appendage: comparison with transesophageal echocardiography in patients undergoing ablation for atrial fibrillation: the Action-Ice I Study. Circ Arrhythm Electrophysiol. 2013 Dec;6(6):1074-81. doi: 10.1161/CIRCEP.113.000504. Epub 2013 Nov 15. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 29, 2015 | |
| Reset | Dec 30, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 29, 2015 | Dec 30, 2015 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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