- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04503122
Baroreflex Sensitivity in Patients Undergoing Ablation of Atrial Fibrillation (BARO-AF)
Baroreflex Sensitivity in Patients Undergoing Atrial Fibrillation Ablation: Association With Arrhythmia Recurrences
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Rodrigue Garcia
- Phone Number: +33549453729
- Email: sec.rythmologie@chu-poitiers.fr
Study Locations
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Poitiers, France
- Recruiting
- CHU De Poitiers
-
Contact:
- Claire BOULETI, Pr
- Email: claire-bouleti@chu-poitiers.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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,
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Recurrence is assessed at one year of follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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;
|
Burden is assessed at one year of follow-up
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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 ;
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Recurrence is assessed at one year of follow-up
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Evolution of baroreflex sensitivity
Time Frame: Before, day 1 and month 3 after the ablation
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To describe the evolution of baroreflex sensitivity in the group with and in the group without recurrence.
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Before, day 1 and month 3 after the ablation
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Biological and imaging parameters
Time Frame: Burden is assessed at one year of follow-up
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To look for an association between biological and imaging parameters and atrial fibrillation burden at 1 year.
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Burden is assessed at one year of follow-up
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Quality of life
Time Frame: before and at one year after atrial fibrillation ablation
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To compare quality of life before and at one year after atrial fibrillation ablation in patients with and without AF recurrence;
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before and at one year after atrial fibrillation ablation
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BARO-AF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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