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Completed

NCT Number: NCT04503122

Baroreflex Sensitivity in Patients Undergoing Ablation of Atrial Fibrillation

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.

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Poitiers

Poitiers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

pulmonary vein isolation

Procedure

pulmonary vein isolation : cryoablation or radiofrequency

Primary outcomes

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

    Time frame: 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 outcomes

  1. Association between baroreflex sensitivity assessed before ablation and atrial fibrillation burden

    Time frame: 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;

  2. Baroreflex sensitivity fall between the groups with and without AF recurrence

    Time frame: 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 ;

  3. Evolution of baroreflex sensitivity

    Time frame: 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.

  4. Biological and imaging parameters

    Time frame: 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.

  5. Quality of life

    Time frame: 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;

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Acronym: BARO-AF

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2020
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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