Baroreflex Sensitivity in Patients Undergoing Ablation of Atrial Fibrillation

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

Sponsors

Lead Sponsor: Poitiers University Hospital

Source Poitiers University Hospital
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.

Overall Status Not yet recruiting
Start Date September 1, 2020
Completion Date October 1, 2022
Primary Completion Date October 1, 2022
Study Type Observational
Primary Outcome
Measure Time Frame
Mean slope assessed before ablation in the recurrence and the non-recurrence groups Recurrence is assessed at one year of follow-up
Secondary Outcome
Measure Time Frame
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
Enrollment 116
Condition
Intervention

Intervention Type: Procedure

Intervention Name: pulmonary vein isolation

Description: pulmonary vein isolation : cryoablation or radiofrequency

Eligibility

Sampling Method: Probability Sample

Criteria:

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,

Gender: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Healthy Volunteers: No

Overall Contact

Last Name: Rodrigue Garcia

Phone: +33549453729

Email: [email protected]

Verification Date

August 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Acronym BARO-AF
Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov