Clinical trial NCT03564327: Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation
Official title: Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation and Interest of the Isochron Map
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the CHU Nimes, CH Béziers and Montpellier for scheduled ablation of paroxysmal or persistent atrial fibrillation by radiofrequency using an electro-anatomical navigation system

Brief summary: 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.


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 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

Primary outcomes:
measure: Atrial fibrillation relapse in non-reducible or non-inducible patients
timeFrame: Month 18
Secondary outcomes:
measure: Atrial fibrillation relapse in non-reducible or non-inducible patients
timeFrame: Month 12
measure: Arrhythmia occurrence in non-reducible or non-inducible patients
timeFrame: Month 12
measure: Arrhythmia occurrence in non-reducible or non-inducible patients
timeFrame: Month 18
measure: Identification of zones of low voltage on voltage maps in non-inducible patients
timeFrame: Day 0
measure: Identification of zones of anisochronic zones on voltage maps in non-inducible patients
timeFrame: Day 0
measure: Maximum variation of conduction speed in the same anatomic region in non-inducible patients
timeFrame: Day 0
measure: Decreasing velocities in the same anatomic region in non-inducible patients
timeFrame: Day 0
measure: Wave front rotation in the same anatomic region in non-inducible patients
timeFrame: Day 0
measure: Total time of radiofrequency in non-inducible patients
timeFrame: Day 0
measure: Total procedure time in non-inducible patients
timeFrame: Day 0
measure: Comparison of lesion volume in non-inducible patients
timeFrame: Day 0
measure: Number and size of treated zones by guided versus conventional ablation in non-inducible patients
timeFrame: Day 0
measure: List locations most frequently treated
timeFrame: Day 0
measure: Survival without relapse of patients treated using the Carto- vs Rhythmia-guided ablation approaches in non-reducible or non-inducible patients
timeFrame: Month 18
measure: Arrhythmia occurrence in non-reducible or non-inducible patients
timeFrame: Month 18
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Montpellier
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU de Montpellier
name: Mathieu Granier, MD
role: PRINCIPAL_INVESTIGATOR
References: