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

Centre Hospitalier Universitaire de Nīmes3 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation

Interventions

Atrial fibrillation ablation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Atrial fibrillation relapse between groups

Atrial fibrillation detected by routine or event-associated Holter examination

Time frame: Month 18

Secondary Outcomes

Atrial fibrillation relapse between groups

Atrial fibrillation detected by routine or event-associated Holter examination

Time frame: Month 12

Arrhythmia occurrence between groups

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

Time frame: Month 12

Arrhythmia occurrence between groups

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

Time frame: Month 18

Concordance of isochrone and voltage maps

Binary yes/no

Time frame: Day 0

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

degrees

Time frame: Day 0

Total time of radiofrequency between groups

Minutes

Time frame: Day 0

Comparison of lesion volume between groups

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

Time frame: Day 0

Total procedure time between groups

Minutes

Time frame: Day 0

Number of treated zones between groups

Time frame: Day 0

Size of treated zones between groups

cm2

Time frame: Day 0

List locations most frequently treated

Number of each

Time frame: Day 0

Survival without relapse of the subgroups paroxysmal versus persistent atrial fibrillation.

Atrial fibrillation detected by routine or event-associated Holter examination

Time frame: Month 18

Survival without relapse of the subgroups treated using the Carto- vs Rhythmia-guided ablation approaches.

Atrial fibrillation detected by routine or event-associated Holter examination

Time frame: Month 18

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes