Ablation of Anisochronous Zones vs Spatio-temporal Dispersal Zones With Antral Electrical Isolation During Radiofrequency Treatment of Paroxysmal or Persistent Atrial Fibrillation

Overview

Using isochronous maps during radiofrequency ablation procedures may identify the driver zones responsible for atrial fibrillation maintenance with greater accuracy compared to a conventional procedure (simple antral isolation of the associated pulmonary veins or, if necessary, combined with removal of spatio-temporal dispersal zones) that do not use isochronous maps, and thus improve the efficiency and safety of atrial fibrillation treatment by radiofrequency treatment.

Full Title of Study: “Comparison of Ablation of Anisochronous Zones vs Spatio-temporal Dispersal Zones in Addition to Antral Electrical Isolation During Radiofrequency Treatment of Paroxysmal or Persistent Atrial Fibrillation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 19, 2020

Interventions

  • Procedure: Atrial fibrillation ablation
    • ablation of Atrial fibrillation using spatio-temporal dispersion
  • Procedure: Atrial fibrillation ablation
    • ablation of concordance zones using isochrone and voltage maps

Arms, Groups and Cohorts

  • Active Comparator: Control
    • ablation of Atrial fibrillation using spatio-temporal dispersion
  • Experimental: Isochrone
    • ablation of concordance zones using isochrone and voltage maps

Clinical Trial Outcome Measures

Primary Measures

  • Atrial fibrillation relapse between groups
    • Time Frame: Month 18
    • Atrial fibrillation detected by routine or event-associated Holter examination

Secondary Measures

  • Atrial fibrillation relapse between groups
    • Time Frame: Month 12
    • Atrial fibrillation detected by routine or event-associated Holter examination
  • Arrhythmia occurrence between groups
    • Time Frame: Month 12
    • Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination
  • Arrhythmia occurrence between groups
    • Time Frame: Month 18
    • Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination
  • Concordance of isochrone and voltage maps
    • Time Frame: Day 0
    • Binary yes/no
  • Maximum variation of conduction speed between variation healthy zones with anisochronic zones in the same anatomic region
    • Time Frame: Day 0
  • Comparison of the decreasing velocities between healthy zones and anisochronic zones in the same anatomic region
    • Time Frame: Day 0
  • Comparison of wave front rotation between healthy zones and anisochronic zones in the same anatomic region
    • Time Frame: Day 0
    • degrees
  • Total time of radiofrequency between groups
    • Time Frame: Day 0
    • Minutes
  • Comparison of lesion volume between groups
    • Time Frame: Day 0
    • Force-time integral, lesion size index or stroke volume index
  • Total procedure time between groups
    • Time Frame: Day 0
    • Minutes
  • Number of treated zones between groups
    • Time Frame: Day 0
  • Size of treated zones between groups
    • Time Frame: Day 0
    • cm2
  • List locations most frequently treated
    • Time Frame: Day 0
    • Number of each
  • Survival without relapse of the subgroups paroxysmal versus persistent atrial fibrillation.
    • Time Frame: Month 18
    • Atrial fibrillation detected by routine or event-associated Holter examination
  • Survival without relapse of the subgroups treated using the Carto- vs Rhythmia-guided ablation approaches.
    • Time Frame: Month 18
    • Atrial fibrillation detected by routine or event-associated Holter examination

Participating in This Clinical Trial

Inclusion Criteria

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient is at least 18 years old
  • The patient has paroxysmal or persistent atrial fibrillation
  • The patient is available for 18 month follow-up

Exclusion Criteria

  • The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • The patient is pregnant or breastfeeding
  • Sinus rhythm has not been able to be determined using external electric cardioversion
  • Patient not susceptible to atrial fibrillation following wide antrum circle ablation
  • The subject has already been included in the study (patients cannot be included more than once)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Nīmes
  • Provider of Information About this Clinical Study
    • Sponsor

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