Ignite Creation Date:
2024-05-05 @ 11:38 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01371279
Status:
UNKNOWN
Last Update Posted:
2011-06-17
First Post:
2011-05-23
Brief Title:
EvaluAtion of Predictive Value of Multisite Intracardiac EchoCardiography During Imaging of Structure and funCTION of Left Atrial Appendage in Comparison to Transesophageal Echocardiography
Sponsor:
Centre of Postgraduate Medical Education
Organization:
Centre of Postgraduate Medical Education
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2011-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ActionICE
Brief Summary:
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 ICEAF 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 RACSPARVOT and esophagus This will be evaluated during the component I of the study
Hypothesis 2 That ICE can identify low risk patients CHADS Score 20 in whom immediate cardioversion during the procedure is as safe as based on conventional strategy
First component will enroll 100 patients these patients will undergo clinically indicated TEE cardiac catheterization procedures with ICEAF 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 RACSPARVOT and esophagus This will be evaluated during the component I of the study
Hypothesis 2 That ICE can identify low risk patients CHADS Score 20 in whom immediate cardioversion during the procedure is as safe as based on conventional strategy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None