Baroreflex Sensitivity in Patients Undergoing Ablation of Atrial Fibrillation

NCT04503122 | Completed

• 1 other identifier: BARO-AF
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Mean slope assessed before ablation in the recurrence and the non-recurrence groups

  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.

  Recurrence is assessed at one year of follow-up

Secondary Outcomes (5)

• Association between baroreflex sensitivity assessed before ablation and atrial fibrillation burden

  Burden is assessed at one year of follow-up

• Baroreflex sensitivity fall between the groups with and without AF recurrence

  Recurrence is assessed at one year of follow-up

• Evolution of baroreflex sensitivity

  Before, day 1 and month 3 after the ablation

• Biological and imaging parameters

  Burden is assessed at one year of follow-up

• Quality of life

  before and at one year after atrial fibrillation ablation

Interventions

pulmonary vein isolation PROCEDURE

pulmonary vein isolation : cryoablation or radiofrequency

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with paroxysmal atrial fibrillation undergoing atrial fibrillation ablation

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU de Poitiers

Poitiers, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 7, 2020
• Study Start: June 22, 2021
• Primary Completion: November 13, 2025
• Study Completion: November 13, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

FR (1)