Clinical trial NCT03564951: Ablation of Anisochronous Zones vs Spatio-temporal Dispersal Zones With Antral Electrical Isolation During Radiofrequency Treatment of Paroxysmal or Persistent Atrial Fibrillation
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Atrial fibrillation relapse between groups
timeFrame: Month 18
Secondary outcomes:
measure: Atrial fibrillation relapse between groups
timeFrame: Month 12
measure: Arrhythmia occurrence between groups
timeFrame: Month 12
measure: Arrhythmia occurrence between groups
timeFrame: Month 18
measure: Concordance of isochrone and voltage maps
timeFrame: Day 0
measure: Maximum variation of conduction speed between variation healthy zones with anisochronic zones in the same anatomic region
timeFrame: Day 0
measure: Comparison of the decreasing velocities between healthy zones and anisochronic zones in the same anatomic region
timeFrame: Day 0
measure: Comparison of wave front rotation between healthy zones and anisochronic zones in the same anatomic region
timeFrame: Day 0
measure: Total time of radiofrequency between groups
timeFrame: Day 0
measure: Comparison of lesion volume between groups
timeFrame: Day 0
measure: Total procedure time between groups
timeFrame: Day 0
measure: Number of treated zones between groups
timeFrame: Day 0
measure: Size of treated zones between groups
timeFrame: Day 0
measure: List locations most frequently treated
timeFrame: Day 0
measure: Survival without relapse of the subgroups paroxysmal versus persistent atrial fibrillation.
timeFrame: Month 18
measure: Survival without relapse of the subgroups treated using the Carto- vs Rhythmia-guided ablation approaches.
timeFrame: Month 18
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Montpellier
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
References: