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Baroreflex Sensitivity in Patients Undergoing Ablation of Atrial Fibrillation

Baroreflex Sensitivity in Patients Undergoing Atrial Fibrillation Ablation: Association With Arrhythmia Recurrences

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04503122
Acronym
BARO-AF
Enrollment
116
Registered
2020-08-07
Start date
2021-06-22
Completion date
2025-11-13
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Atrial Fibrillation

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.

Interventions

PROCEDUREpulmonary vein isolation

pulmonary vein isolation : cryoablation or radiofrequency

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frameDescription
Mean slope assessed before ablation in the recurrence and the non-recurrence groupsRecurrence is assessed at one year of follow-upTo 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

MeasureTime frameDescription
Association between baroreflex sensitivity assessed before ablation and atrial fibrillation burdenBurden is assessed at one year of follow-upAssociation 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;
Baroreflex sensitivity fall between the groups with and without AF recurrenceRecurrence is assessed at one year of follow-upTo 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 sensitivityBefore, day 1 and month 3 after the ablationTo describe the evolution of baroreflex sensitivity in the group with and in the group without recurrence.
Biological and imaging parametersBurden is assessed at one year of follow-upTo look for an association between biological and imaging parameters and atrial fibrillation burden at 1 year.
Quality of lifebefore and at one year after atrial fibrillation ablationTo compare quality of life before and at one year after atrial fibrillation ablation in patients with and without AF recurrence;

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026