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
  Purpose

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 Intervention Phase
Atrial Fibrillation
Device: Intra-Cardiac Echocardiography guided atrial fibrillation ablation
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Medical Centre of Postgraduate Education, Poland:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: June 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Intra-Cardiac Echocardiography guided atrial fibrillation ablation
    8-F or 10-F phase array ICE-probe
    Other Name: AcuNav Siemens Ag Medical Solution
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01371279

Contacts
Contact: Piotr Kulakowski, Prof. 0048228105030 kulak@kkcmkp.pl
Contact: Sebastian M Stec, PhD 0048512221279 smstec@wp.pl

Locations
Poland
Department of Cardiology, Postgraduate Medical School, Grochowski Hospital, Grenadierow 51/59 Recruiting
Warsaw, Poland, 04 073
Contact: Sebastian M Stec, PhD    0048512221279    smstec@wp.pl   
Contact: Jakub Baran, MD    0048697604544    j.baran@sampi.pl   
Sub-Investigator: Jakub Baran, MD         
Principal Investigator: Sebastian M Stec, PhD         
Sponsors and Collaborators
Medical Centre of Postgraduate Education, Poland
  More Information

No publications provided by Medical Centre of Postgraduate Education, Poland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sebastian M.Stec / Jakub Baran, Medical Centre of Postgraduate Education, Poland
ClinicalTrials.gov Identifier: NCT01371279     History of Changes
Other Study ID Numbers: 1-Stec
Study First Received: May 23, 2011
Last Updated: June 16, 2011
Health Authority: Poland: Ethics Committee

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014