EvaluAtion of Predictive Value of Multisite Intracardiac EchoCardiography During Imaging of Structure and funCTION of Left Atrial Appendage in Comparison to Transesophageal Echocardiography (ActionICE)
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|ClinicalTrials.gov Identifier: NCT01371279|
Recruitment Status : Unknown
Verified March 2011 by Centre of Postgraduate Medical Education.
Recruitment status was: Recruiting
First Posted : June 10, 2011
Last Update Posted : June 17, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: Intra-Cardiac Echocardiography guided atrial fibrillation ablation||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||EvaluAtion of Predictive Value of Multisite Intracardiac EchoCardiography During Imaging of Structure and funCTION of Left Atrial Appendage in Comparison to Transesophageal Echocardiography|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||February 2013|
|Estimated Study Completion Date :||March 2013|
- Device: Intra-Cardiac Echocardiography guided atrial fibrillation ablation
8-F or 10-F phase array ICE-probeOther Name: AcuNav Siemens Ag Medical Solution
- Predictive value of ICE compared to TEE in visualisation of morphology and thrombus in LAA. [ Time Frame: intraoperative - up to six hours ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01371279
|Contact: Piotr Kulakowski, Prof.||firstname.lastname@example.org|
|Contact: Sebastian M Stec, PhDemail@example.com|
|Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Grenadierow 51/59||Recruiting|
|Warsaw, Poland, 04 073|
|Contact: Sebastian M Stec, PhD 0048512221279 firstname.lastname@example.org|
|Contact: Jakub Baran, MD 0048697604544 email@example.com|
|Sub-Investigator: Jakub Baran, MD|
|Principal Investigator: Sebastian M Stec, PhD|