Baroreflex Sensitivity in Patients Undergoing Ablation of Atrial Fibrillation

Active, not recruiting

• Conditions: Paroxysmal Atrial Fibrillation

• Registration Number: NCT04503122
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-07
• Study Start: 2021-01-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-16
• Last Update Posted: 2024-11-19
• Primary Completion: 2025-11-15
• Study Completion: 2025-11-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 116

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,

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean slope assessed before ablation in the recurrence and the non-recurrence groups	Recurrence is assessed at one year of follow-up	To compare baroreflex sensitivity assessed by mean Slope 1 month before the ablation in the recurrence group at 1 year and in the no AF recurrence group at 1 year.

Secondary Outcome Measures

Name	Time	Method
Baroreflex sensitivity fall between the groups with and without AF recurrence	Recurrence is assessed at one year of follow-up	To compare the baroreflex sensitivity fall between before and day1 of ablation between the groups with and without AF recurrence at 1 year follow-up ;
Evolution of baroreflex sensitivity	Before, day 1 and month 3 after the ablation	To describe the evolution of baroreflex sensitivity in the group with and in the group without recurrence.
Association between baroreflex sensitivity assessed before ablation and atrial fibrillation burden	Burden is assessed at one year of follow-up	Association between baroreflex sensitivity evaluated by mean slope, LF gain and HF gain 1 month before AF ablation and AF burden after 1 year of follow-up;
Quality of life	before and at one year after atrial fibrillation ablation	To compare quality of life before and at one year after atrial fibrillation ablation in patients with and without AF recurrence;
Biological and imaging parameters	Burden is assessed at one year of follow-up	To look for an association between biological and imaging parameters and atrial fibrillation burden at 1 year.

Trial Locations

Locations (1)

CHU de Poitiers; 🇫🇷 Poitiers, France