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

Status unconfirmed · Not applicable

Conditions studied: Atrial Flutter

In brief

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.

Key facts

Study ID

NCT05229848

Run by

Kansas City Heart Rhythm Research Foundation

People needed

60

Starts

2022-02-01

Expected to finish

2022-04-01

Last updated by the study team

2022-02-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients undergoing typical CTI dependent AFL who give informed consent for participation in the study will be included.

You may not qualify if…

• Patients in whom placement of an ICE catheter in the right atrium for adequate atrial visualization is technically not feasible.
• Patients who cannot give an informed consent will be excluded.
• Patients in who vascular access for the 11F sheath is not feasible will be excluded. Those with left iliac vein stenosis or left groin arteriovenous (AV) fistulas or prior left groin access complications will be excluded.
• Patients who on the EP (Electrophysiology) study are found to have a left sided arrhythmia needing transseptal access will be excluded.
• Patients who during EP study are found to have atypical flutter pathways including Left Atrial (LA)/Left sided flutter as above, atypical pathways outside of the CTI, and scar based- reentry pathways.

Where it is running

• Midwest Heart and Vascular Specialists — Overland Park, Kansas, United States
• Overland Park Regional Medical Center — Overland Park, Kansas, United States
• Kansas City Heart Rhythm Institute — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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