First Ablation of Atrial Fibrillation Clinical Trial
— VARIABLEOfficial title:
Predictive Value of Aortic Stiffness on Recurrence of Atrial Fibrillation After Disconnection of Pulmonary Veins.
The ablation of atrial fibrillation (FA) by disconnection of pulmonary veins is a burgeoning
intervention. It allows a long-term treatment of this arrhythmia with a success rate of about
80%. There are, nevertheless, some recidivism.
Risk factors for recidivism are poorly codified and need further research. Indeed the
identification of factors of poor prognosis could lead to not propose this procedure to the
patients who present them and at least to inform them of an increased risk of failure.
To date, aortic stiffness has not been studied in the context of assessing the risk factors
for FA recurrence after ablation. On a physiopathological level, the aortic stiffness leads
to increase left ventricle's post-load. Cardiac remodeling was observed with diastolic
dysfunction and increased left atrial size. That may constitute a substrate for FA
recurrence.
In the literature, aortic stiffness can be measured in several ways:
1. Measurement of systolo-diastolic variation of the inner diameter of the aorta by scanner
or transesophageal Echography (ETO).
2. Measuring of the Pulse Wave Velocity.
3. Measurement of aortic calcifications.
The investigators propose to evaluate the impact of aortic stiffness on the recidivism of FA
6 months after ablation procedure performed in the Croix-Rousse cardiology's department.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | May 2018 |
| Est. primary completion date | May 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria : - 18 years old of both sexes, - Patient carrying a paroxysmal or persistent atrial fibrillation, benefiting from a first procedure of atrial fibrillation's ablation in the in the Croix-Rousse cardiology's department. - Patient who signed the consent to participate in the study. Exclusion Criteria : - Patient carrying a permanent atrial fibrillation - Patient who're in atrial fibrillation during the ablation - Atrial fibrillation relapse's history after ablation - Pregnant and nursing women - Patients refusal. |
| Country | Name | City | State |
|---|---|---|---|
| France | Hospices Civils de Lyon - Hôpital de la Croix Rousse | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Atrial fibrillation recurrences | Atrial fibrillation recurrences after 6 months of ablation by Holter ECG | Month 6 |