Clinical trial NCT04503122: Baroreflex Sensitivity in Patients Undergoing Ablation of Atrial Fibrillation
Official title: Baroreflex Sensitivity in Patients Undergoing Atrial Fibrillation Ablation: Association with Arrhythmia Recurrences
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with paroxysmal atrial fibrillation undergoing atrial fibrillation ablation

Brief summary: Atrial fibrillation is the most common arrhythmia. The posterior surface of the left atrium is covered by an extensive network belonging to the autonomic nervous system that can be damaged during the ablation. The involvement of the autonomous nervous system in the genesis and maintenance of atrial fibrillation remains poorly understood. Baroreflex sensitivity is a non-invasive method assessing autonomous nervous system activity.

The rate of atrial fibrillation recurrence after ablation is currently high and a better understanding of the mechanisms associated with recurrence is essential to improve selection of the patients who will benefit the most from this procedure.

The aim of this study is to evaluate the association between the baroreflex sensitivity and atrial fibrillation recurrences and to analyze the prognostic contribution of the baroreflex measurement compared to other published criteria.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old,
* Patients with paroxysmal atrial fibrillation, hospitalized for atrial fibrillation ablation,
* Assessable baroreflex sensitivity before ablation,
* Free subject, without guardianship or curatorship or subordination,
* Patients benefiting from a Social Security assurance,
* Informed consent signed by the patient after clear and fair information about the study.

Exclusion Criteria:

* Age \< 18,
* History of atrial fibrillation ablation,
* Inability to calculate the baroreflex sensitivity
* Contraindication to the performance of a cardiac CT scan (allergy to iodine, severe renal insufficiency with clearance \<30 ml/mn/m2),
* Inability to have continuous ECG recording by subcutaneous Holter,

Primary outcomes:
measure: Mean slope assessed before ablation in the recurrence and the non-recurrence groups
timeFrame: Recurrence is assessed at one year of follow-up
Secondary outcomes:
measure: Association between baroreflex sensitivity assessed before ablation and atrial fibrillation burden
timeFrame: Burden is assessed at one year of follow-up
measure: Baroreflex sensitivity fall between the groups with and without AF recurrence
timeFrame: Recurrence is assessed at one year of follow-up
measure: Evolution of baroreflex sensitivity
timeFrame: Before, day 1 and month 3 after the ablation
measure: Biological and imaging parameters
timeFrame: Burden is assessed at one year of follow-up
measure: Quality of life
timeFrame: before and at one year after atrial fibrillation ablation
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
References: