Baroreflex Sensitivity in Patients Undergoing Ablation of Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

— BARO-AF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04503122
• Other study ID #: BARO-AF
• Status: Recruiting
• Start date: January 12, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: January 2021
• Source: Poitiers University Hospital
• Contact: Rodrigue Garcia
• Phone: +33549453729
• Email: sec.rythmologie[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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,

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Procedure:
• pulmonary vein isolation
pulmonary vein isolation : cryoablation or radiofrequency

Locations

Country	Name	City	State
France	CHU de Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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;	Burden is assessed at one year of follow-up
Secondary	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 ;	Recurrence is assessed at one year of follow-up
Secondary	Evolution of baroreflex sensitivity	To describe the evolution of baroreflex sensitivity in the group with and in the group without recurrence.	Before, day 1 and month 3 after the ablation
Secondary	Biological and imaging parameters	To look for an association between biological and imaging parameters and atrial fibrillation burden at 1 year.	Burden is assessed at one year of follow-up
Secondary	Quality of life	To compare quality of life before and at one year after atrial fibrillation ablation in patients with and without AF recurrence;	before and at one year after atrial fibrillation ablation