Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation

Overview

This study is an ancillary study to Isochrone-AF. The investigators hypothesize that patients eligible but non-included in the primary study (patients classified as non-reducible or non-inducible) will have different prognosis and electro-physiclogical characteristics to the patients included and randomized into the Isochrone AF study.

Full Title of Study: “Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation and Interest of the Isochron Map”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 2022

Interventions

  • Procedure: Wide antrum circle ablation
    • As standard hospital policy
  • Procedure: External electric cardioversion
    • Three attempts (200-250 joules)

Arms, Groups and Cohorts

  • Patients with sinus rhythm
  • patients with atrial fibrillation

Clinical Trial Outcome Measures

Primary Measures

  • Atrial fibrillation relapse in non-reducible or non-inducible patients
    • Time Frame: Month 18
    • Atrial fibrillation detected by routine or event-associated Holter examination

Secondary Measures

  • Atrial fibrillation relapse in non-reducible or non-inducible patients
    • Time Frame: Month 12
    • Atrial fibrillation detected by routine or event-associated Holter examination
  • Arrhythmia occurrence in non-reducible or non-inducible patients
    • Time Frame: Month 12
    • Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination
  • Arrhythmia occurrence in non-reducible or non-inducible patients
    • Time Frame: Month 18
    • Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination
  • Identification of zones of low voltage on voltage maps in non-inducible patients
    • Time Frame: Day 0
    • Yes/No
  • Identification of zones of anisochronic zones on voltage maps in non-inducible patients
    • Time Frame: Day 0
    • Yes/No
  • Maximum variation of conduction speed in the same anatomic region in non-inducible patients
    • Time Frame: Day 0
  • Decreasing velocities in the same anatomic region in non-inducible patients
    • Time Frame: Day 0
  • Wave front rotation in the same anatomic region in non-inducible patients
    • Time Frame: Day 0
    • degrees
  • Total time of radiofrequency in non-inducible patients
    • Time Frame: Day 0
    • Minutes
  • Total procedure time in non-inducible patients
    • Time Frame: Day 0
    • Minutes
  • Comparison of lesion volume in non-inducible patients
    • Time Frame: Day 0
    • Force-time integral, lesion size index or stroke volume index
  • Number and size of treated zones by guided versus conventional ablation in non-inducible patients
    • Time Frame: Day 0
    • cm2
  • List locations most frequently treated
    • Time Frame: Day 0
    • Number of each
  • Survival without relapse of patients treated using the Carto- vs Rhythmia-guided ablation approaches in non-reducible or non-inducible patients
    • Time Frame: Month 18
    • Atrial fibrillation detected by routine or event-associated Holter examination
  • Arrhythmia occurrence in non-reducible or non-inducible patients
    • 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 is available for 18 month follow-up – The patient has paroxysmal or persistent atrial fibrillation 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 Early Study Exit Criteria: Patient does not have paroxysmal or persistent AF at the time of inclusion

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
  • Overall Official(s)
    • Mathieu Granier, MD, Principal Investigator, CHU de Montpellier
  • Overall Contact(s)
    • Mathieu Granier, MD, 04.67.33.67.33, m-granier@chu-montpellier.fr

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