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CompletedNCT04503122BARO-AFUpdated Dec 24, 2025

Baroreflex Sensitivity in Patients Undergoing Ablation of Atrial Fibrillation

An observational study in Paroxysmal Atrial Fibrillation, sponsored by Poitiers University Hospital. Completed at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by Poitiers University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
116
Ages
18 Years to 99 Years
Sex
All
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Study 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.

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Conditions studied

  • Paroxysmal Atrial Fibrillation

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In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 116 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Poitiers University Hospital is the lead sponsor of 310 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients with paroxysmal atrial fibrillation undergoing atrial fibrillation ablation

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

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,
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
116 participants (actual)
Patient registry
No

Interventions

  • Procedurepulmonary vein isolation

    pulmonary vein isolation : cryoablation or radiofrequency

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What researchers measure

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.

    Time frame: Recurrence is assessed at one year of follow-up

Secondary outcomes

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

    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;

    Time frame: Burden is assessed at one year of follow-up

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

    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 ;

    Time frame: Recurrence is assessed at one year of follow-up

  3. Evolution of baroreflex sensitivity

    To describe the evolution of baroreflex sensitivity in the group with and in the group without recurrence.

    Time frame: Before, day 1 and month 3 after the ablation

  4. Biological and imaging parameters

    To look for an association between biological and imaging parameters and atrial fibrillation burden at 1 year.

    Time frame: Burden is assessed at one year of follow-up

  5. Quality of life

    To compare quality of life before and at one year after atrial fibrillation ablation in patients with and without AF recurrence;

    Time frame: before and at one year after atrial fibrillation ablation

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Study locations

1 site
  • CHU de Poitiers
    Poitiers, France
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04503122
Lead sponsor
Poitiers University Hospital
Responsible party
Sponsor
First posted
Aug 7, 2020
Start date
Jun 22, 2021
Primary completion
Nov 13, 2025
Completion
Nov 13, 2025
Last update
Dec 24, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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