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ICE Based Atrial Flutter Ablation Vs Conventional Fluoroscopy/Anatomical Mapping Based Ablation - ICE Flutter Study

NCT05229848 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-02-08

No results posted yet for this study

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.

Conditions

  • Atrial Flutter

Interventions

PROCEDURE

3D electroanatomical mapping alone guided CTI ablation

3D electroanatomical mapping in combination with fluoroscopy has been traditionally used in conventional CTI ablation for AFL.

PROCEDURE

ICE plus 3D electroanatomical mapping guided CTI ablation

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.

Sponsors & Collaborators

  • Kansas City Heart Rhythm Research Foundation

    lead OTHER

Principal Investigators

  • Dhanunjaya Lakkireddy, MD · Kansas City Heart Rhythm Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05229848 on ClinicalTrials.gov