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Status:

UNKNOWN

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

Lead Sponsor:

Kansas City Heart Rhythm Research Foundation

Conditions:

Atrial Flutter

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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...

Detailed Description

Atrial flutter (AFL) is a re-entrant tachyarrhythmia that involves the atria that leads to both rapid ventricular rates as well as a loss of effective contractility of the atrial making them vulnerabl...

Eligibility Criteria

Inclusion

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

Exclusion

    Key Trial Info

    Start Date :

    February 1 2022

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    April 1 2022

    Estimated Enrollment :

    60 Patients enrolled

    Trial Details

    Trial ID

    NCT05229848

    Start Date

    February 1 2022

    End Date

    April 1 2022

    Last Update

    February 8 2022

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    Kansas City Heart Rhythm Institute

    Overland Park, Kansas, United States, 66211

    2

    Midwest Heart and Vascular Specialists

    Overland Park, Kansas, United States, 66211

    3

    Overland Park Regional Medical Center

    Overland Park, Kansas, United States, 66215