Clinical trial NCT04045067: Low-voltage Areas Defragmentation in Sinus Rhythm for Radiofrequency Ablation of Persistent Atrial Fibrillation
Official title: Low-voltage Areas Defragmentation in Sinus Rhythm for Radiofrequency Ablation of Persistent Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Atrial Fibrillation, Persistent
Keywords: Ablation
Low voltage areas
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients included in this protocol will be recruited by the centers that practice the procedure of ablation of persistent atrial fibrillation, by transcutaneous vein and trans-septal catheterization. Participation in this prospective observational study has been proposed to all centers practicing this procedure in France, regardless of the technique used. Inclusion in the study will be systematically offered to each patient who will benefit from this technique.

Brief summary: This is a study evaluating the value of defragmentation of sinus rhythmic low voltage areas in addition to isolation of pulmonary veins in the removal of recurrent atrial fibrillation. The invasive procedure will be performed according to the procedures chosen by the rhythmologist and will in no way be modified by the patient's enrollment in the study. Similarly, the frequency of consultations, date and nature of the additional examinations will be defined by the physician, with the purpose of monitoring the patient.

Detailed description: Radiofrequency ablation has become standard practice in the approach strategy for the symptomatic treatment of atrial fibrillation. The interest of substrate ablation, completing the isolation of the pulmonary veins is controversial. The usual technique for the ablation of recurrent atrial fibrillation is primarily a disconnection of the pulmonary veins, which can be accomplished by isolating the veins one by one or two by two. The isolation of the pulmonary veins is followed most often by a defragmentation of the atrium (ablation of the substrate). The defragmentation is guided by a map of fragmented potentials, made through a topography catheter, to locate the most abnormal areas that are the target of ablation. This strategy requires extensive ablation of the left atrium, with a long procedure time and repeated many radiofrequency shots. On the one hand there is a risk of complication related to the duration of intervention, but also in the longer term of occurrence of flutter scar. In addition to pulmonary vein isolation, the goal is to identify patients with sinus rhythm atrial arrhythmogenic substrate. Once the sinus rhythm has been restored by electrical cardioversion or spontaneously, a voltage map is carried out to identify the most abnormal (low voltage) areas, and intra-atrial fragmented potentials are identified, either spontaneously or spontaneously by the extra-stimulus method. Ablation of these abnormal areas may lead to better long-term results, limiting prolonged radiofrequency shots and complications associated with longer procedure times.

Eligibility criteria: Inclusion Criteria:

* Patients with persistent atrial fibrillation ablation, no specific indication restrictions or equipment used and regardless of the outcome of the procedure
* Patients participating in a biomedical research can participate in this study.

Exclusion Criteria:

* Pregnant or lactating women can not participate in this study

Primary outcomes:
measure: Evaluation of the success rate of the procedures
timeFrame: month 18
Secondary outcomes:
measure: Evaluation of the efficiency of the procedures
timeFrame: Day 1
measure: Evaluation of the safety of the procedures
timeFrame: Day 1 / month 3 / month 6 / month 12 / month 18
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
city: Caluire-et-Cuire
country: France
facility: Clinique de l'Infirmerie Protestante de Lyon
city: Lyon
country: France
facility: Centre Hospitalier Saint Joseph Saint Luc
city: Marseille
country: France
facility: Hôpital Saint-Joseph
city: Marseille
country: France
facility: Hôpital Privé Beauregard
city: Neuilly-sur-Seine
country: France
facility: Clinique Ambroise Paré
city: Paris
country: France
facility: Hôpital Universitaire Pitié Salpêtrière
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord
city: Tours
country: France
facility: Clinique Saint Gatien
Study officials:
affiliation: Centre Cardiologique du Nord
name: Antoine LEPILLIER, MD
role: PRINCIPAL_INVESTIGATOR
References: