At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective Comparison of ICE Based Atrial Flutter Ablation Vs Conventional Fluoroscopy/Anatomical Mapping Based Ablation
In Brief
A clinical study evaluating 3D electroanatomical mapping alone guided CTI ablation and ICE plus 3D electroanatomical mapping guided CTI ablation for Atrial Flutter. Targeting 60 participants across 3 sites.
Detailed Summary
Intracardiac echocardiography (ICE), has been an essential component of Radiofrequency (RF) ablations for AF given its association with decreased fluoroscopy time and complication rates, and therefore it is logical that this can be applied to CTI ablations for AFL as well. There are however no studies to date that directly focused on the benefits of adding ICE during CTI dependent AFL ablation. Currently it is not required that operators use ICE in every case of AFL ablation. Investigators intended to study the routine use of ICE in such cases and to see if there is a significant benefit in routine use of ICE.
Study Details
Timeline
Interventions
3D electroanatomical mapping in combination with fluoroscopy has been traditionally used in conventional CTI ablation for AFL.
ICE imaging catheter is typically introduced through an 11-F hemostatic sheath and positioned under fluoroscopic guidance in the right atrium. After catheter coupling to the imaging platform, imaging frequency is optimized by the operator using adjunctive gain, depth, and focal length controls to define anatomic structures and minimize noise. Imaging is performed at different levels in the right atrium, if needed. Imaging targets included the right atrium, coronary sinus orifice, fossa ovalis, interatrial septum (IAS), tricuspid valve, left atrium, left atrial appendage, orifice of all pulmonary veins, mitral valve, papillary muscles, aortic and pulmonary valve leaflets, right ventricle, RVOT, pericardial space, esophagus, aorta and adjoining left ventricular and right ventricular myocardium.