A Phase 4 interventional study of Intra-Cardiac Echocardiography guided atrial fibrillation ablation in Atrial Fibrillation, sponsored by Centre of Postgraduate Medical Education. Status unknown at 1 site in Poland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-06-17.
Sponsored by Centre of Postgraduate Medical Education · Phase 4, Interventional, and Diagnostic
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 100 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Centre of Postgraduate Medical Education is the lead sponsor of 45 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
8-F or 10-F phase array ICE-probe
Also known as: AcuNav Siemens Ag Medical Solution
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.
Time frame: intraoperative - up to six hours
This study is status unknown, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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Centre of Postgraduate Medical Education