EvaluAtion of Predictive Value of Multisite Intracardiac EchoCardiography During Imaging of Structure and funCTION of Left Atrial Appendage in Comparison to Transesophageal Echocardiography (ActionICE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Medical Centre of Postgraduate Education, Poland.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical Centre of Postgraduate Education, Poland
ClinicalTrials.gov Identifier:
NCT01371279
First received: May 23, 2011
Last updated: June 16, 2011
Last verified: March 2011

May 23, 2011
June 16, 2011
June 2011
February 2013   (final data collection date for primary outcome measure)
Predictive value of ICE compared to TEE in visualisation of morphology and thrombus in LAA. [ Time Frame: intraoperative - up to six hours ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01371279 on ClinicalTrials.gov Archive Site
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EvaluAtion of Predictive Value of Multisite Intracardiac EchoCardiography During Imaging of Structure and funCTION of Left Atrial Appendage in Comparison to Transesophageal Echocardiography
EvaluAtion of Predictive Value of Multisite Intracardiac EchoCardiography During Imaging of Structure and funCTION of Left Atrial Appendage in Comparison to Transesophageal Echocardiography

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Atrial Fibrillation
Device: Intra-Cardiac Echocardiography guided atrial fibrillation ablation
8-F or 10-F phase array ICE-probe
Other Name: AcuNav Siemens Ag Medical Solution
Not Provided
Baran J, Stec S, Pilichowska-Paszkiet E, Zaborska B, Sikora-Frąc M, Kryński T, Michałowska I, Łopatka R, Kułakowski 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with paroxysmal/persistent AF
  2. Patients with or without structural Heart Disease.
  3. Men or Women aged 18 years or older.
  4. Patients undergoing an invasive catheterization procedure including right heart catheterization.
  5. Patients who give an informed consent for participation in the study.
  6. Patients who have undergone a trans-esophageal echocardiogram within the last 48 hours. Patient witch CHADS2 score > 2

Exclusion Criteria:

  1. Patients in whom placement of an ICE catheter for adequate atrial visualization is technically not feasible (Right atrium or Esophagus).
  2. Women of child bearing potential, in whom pregnancy cannot be excluded.
  3. Patients with any medical condition or social circumstance, which in the opinion of the investigator, would make the patient's successful completion of the study doubtful
Both
18 Years to 75 Years
No
Contact: Piotr Kulakowski, Prof. 0048228105030 kulak@kkcmkp.pl
Contact: Sebastian M Stec, PhD 0048512221279 smstec@wp.pl
Poland
 
NCT01371279
1-Stec
No
Sebastian M.Stec / Jakub Baran, Medical Centre of Postgraduate Education, Poland
Medical Centre of Postgraduate Education, Poland
Not Provided
Not Provided
Medical Centre of Postgraduate Education, Poland
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP