Paroxysmal Atrial FibrillationBARO-AFNCT04503122
Baroreflex Sensitivity in Patients Undergoing Ablation of Atrial Fibrillation
An observational study of Paroxysmal Atrial Fibrillation, run by Poitiers University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- pulmonary vein isolation
- Type of treatment
- Surgery or procedure
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2021to 13 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with paroxysmal atrial fibrillation undergoing atrial fibrillation ablation
Who may be able to join
- 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.
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- pulmonary vein isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary vein isolationProcedure or surgery
pulmonary vein isolation : cryoablation or radiofrequency
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Recurrence is assessed at one year of follow-up
Secondary outcomes (5)
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;
Measured: Burden is assessed at one year of follow-up
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 ;
Measured: Recurrence is assessed at one year of follow-up
Evolution of baroreflex sensitivity
To describe the evolution of baroreflex sensitivity in the group with and in the group without recurrence.
Measured: Before, day 1 and month 3 after the ablation
Biological and imaging parameters
To look for an association between biological and imaging parameters and atrial fibrillation burden at 1 year.
Measured: Burden is assessed at one year of follow-up
Quality of life
To compare quality of life before and at one year after atrial fibrillation ablation in patients with and without AF recurrence;
Measured: before and at one year after atrial fibrillation ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start22 Jun 2021
- Primary completion13 Nov 2025
- Study completion13 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503122
- Sponsor's protocol ID
- BARO-AF
- Acronym
- BARO-AF
- Status last verified
- Dec 2025
- First submitted
- 3 Aug 2020
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baroreflex Sensitivity in Patients Undergoing Atrial Fibrillation Ablation: Association With Arrhythmia Recurrences
- ClinicalTrials.gov ID
- NCT04503122
- Acronym / sponsor ID
- BARO-AF / BARO-AF
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 13 Nov 2025 (actual)
- Study completion
- 13 Nov 2025 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with paroxysmal atrial fibrillation undergoing atrial fibrillation ablation
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulmonary vein isolationpulmonary vein isolation : cryoablation or radiofrequency | Procedure or surgery | – |
Primary outcome
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.
5 secondary outcomes
Association between baroreflex sensitivity assessed before ablation and atrial fibrillation burden
Time frame: Burden is assessed at one year of follow-up
Baroreflex sensitivity fall between the groups with and without AF recurrence
Time frame: Recurrence is assessed at one year of follow-up
Evolution of baroreflex sensitivity
Time frame: Before, day 1 and month 3 after the ablation
Biological and imaging parameters
Time frame: Burden is assessed at one year of follow-up
Quality of life
Time frame: before and at one year after atrial fibrillation ablation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paroxysmal Atrial Fibrillation, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean slope assessed before ablation in the recurrence and the non-recurrence groups (time frame: Recurrence is assessed at one year of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.