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Completed

NCT Number: NCT03564951

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Montpellier, Montpellier, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Atrial fibrillation ablation

Procedure

ablation of Atrial fibrillation using spatio-temporal dispersion

Primary outcomes

  1. Atrial fibrillation relapse between groups

    Time frame: Month 18

    Atrial fibrillation detected by routine or event-associated Holter examination

Secondary outcomes

  1. Atrial fibrillation relapse between groups

    Time frame: Month 12

    Atrial fibrillation detected by routine or event-associated Holter examination

  2. Arrhythmia occurrence between groups

    Time frame: Month 12

    Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination

  3. Arrhythmia occurrence between groups

    Time frame: Month 18

    Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination

  4. Concordance of isochrone and voltage maps

    Time frame: Day 0

    Binary yes/no

  5. Maximum variation of conduction speed between variation healthy zones with anisochronic zones in the same anatomic region

    Time frame: Day 0

  6. Comparison of the decreasing velocities between healthy zones and anisochronic zones in the same anatomic region

    Time frame: Day 0

  7. Comparison of wave front rotation between healthy zones and anisochronic zones in the same anatomic region

    Time frame: Day 0

    degrees

  8. Total time of radiofrequency between groups

    Time frame: Day 0

    Minutes

  9. Comparison of lesion volume between groups

    Time frame: Day 0

    Force-time integral, lesion size index or stroke volume index

  10. Total procedure time between groups

    Time frame: Day 0

    Minutes

  11. Number of treated zones between groups

    Time frame: Day 0

  12. Size of treated zones between groups

    Time frame: Day 0

    cm2

  13. List locations most frequently treated

    Time frame: Day 0

    Number of each

  14. 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

  15. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: ISOCHRONE-AF

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 21, 2018
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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