Baroreflex Sensitivity in Patients Undergoing Ablation of Atrial Fibrillation (BARO-AF)

January 28, 2021 updated by: Poitiers University Hospital

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

Recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with paroxysmal atrial fibrillation undergoing atrial fibrillation ablation

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Recurrence is assessed at one year of follow-up

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
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 ;
Recurrence is assessed at one year of follow-up
Evolution of baroreflex sensitivity
Time Frame: Before, day 1 and month 3 after the ablation
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
Biological and imaging parameters
Time Frame: Burden is assessed at one year of follow-up
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
Quality of life
Time Frame: before and at one year after atrial fibrillation ablation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

August 3, 2020

First Submitted That Met QC Criteria

August 3, 2020

First Posted (Actual)

August 7, 2020

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • BARO-AF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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