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

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: Atrial fibrillation ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03564951

NIMAO/2017-02/MG-01

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Control

Active Comparator group

Description:

ablation of Atrial fibrillation using spatio-temporal dispersion

Treatment:

Procedure: Atrial fibrillation ablation

Procedure: Atrial fibrillation ablation

Isochrone

Experimental group

Description:

ablation of concordance zones using isochrone and voltage maps

Treatment:

Procedure: Atrial fibrillation ablation

Procedure: Atrial fibrillation ablation