Baroreflex Sensitivity in Patients Undergoing Ablation of Atrial Fibrillation

NCT ID: NCT04503122

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-22

Study Completion Date

2025-11-13

Brief Summary

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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

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Conditions

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Paroxysmal Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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pulmonary vein isolation

pulmonary vein isolation : cryoablation or radiofrequency

Intervention Type PROCEDURE

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Poitiers

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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BARO-AF

Identifier Type: -

Identifier Source: org_study_id