NCT01371279

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Centre of Postgraduate Medical Education · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Intra-Cardiac Echocardiography guided atrial fibrillation ablation	8-F or 10-F phase array ICE-probe

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-02-01
• Completion: 2013-03-01
• First posted: 2011-06-10
• Last updated: 2011-06-17

Locations

1 site across 1 country: Poland