Atrial Fibrillation
Conditions
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.
Interventions
PROCEDUREAtrial fibrillation ablation
ablation of Atrial fibrillation using spatio-temporal dispersion
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial fibrillation relapse between groups | Month 18 | Atrial fibrillation detected by routine or event-associated Holter examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arrhythmia occurrence between groups | Month 12 | Arrhythmia, including atrial tachycardia detected by routine or event-associated Holter examination |
| Concordance of isochrone and voltage maps | Day 0 | Binary yes/no |
| Maximum variation of conduction speed between variation healthy zones with anisochronic zones in the same anatomic region | Day 0 | — |
| Comparison of the decreasing velocities between healthy zones and anisochronic zones in the same anatomic region | Day 0 | — |
| Comparison of wave front rotation between healthy zones and anisochronic zones in the same anatomic region | Day 0 | degrees |
| Total time of radiofrequency between groups | Day 0 | Minutes |
| Atrial fibrillation relapse between groups | Month 12 | Atrial fibrillation detected by routine or event-associated Holter examination |
| Total procedure time between groups | Day 0 | Minutes |
| Number of treated zones between groups | Day 0 | — |
| Size of treated zones between groups | Day 0 | cm2 |
| List locations most frequently treated | Day 0 | Number of each |
| Survival without relapse of the subgroups paroxysmal versus persistent atrial fibrillation. | Month 18 | Atrial fibrillation detected by routine or event-associated Holter examination |
| Survival without relapse of the subgroups treated using the Carto- vs Rhythmia-guided ablation approaches. | Month 18 | Atrial fibrillation detected by routine or event-associated Holter examination |
| Comparison of lesion volume between groups | Day 0 | Force-time integral, lesion size index or stroke volume index |
Countries
France
Outcome results
None listed