Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the acute efficacy of ablation of the most stable VX1 areas (levels 2 and 3) in terms of the rate of acute AF termination.
Identify the spatial distribution of dispersion stability levels based on VX1. Document the rate of adverse events. To assess the long-term efficacy of ablation of the most stable VX1 areas in terms of the absence of documented arrhythmias during a 12-month follow-up.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Software VX1 + Stability | Experimental | Utilization of the software VX1 + Stability |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AF ablation | Procedure | AF ablation using the Volta Medical VX1 CE marked software and a new criteria to establish a priority of the dispersed zones according to the stability of the core algorithm's response (thanks to the new software module under study named "stability"). |
| Measure | Description | Time Frame |
|---|---|---|
| AF termination rate after ablation of the most stable regions (levels 3 and 2) | sinus rhythm at the end of the procedure | at the end of the procedure |
Not provided
Not provided
Inclusion Criteria:
Patients 18 years of age or older candidates with Persistent or long-standing persistent AF with documentation of (ECG, Holter, physician's letter):
Continuous anticoagulation with warfarin (INR 2-3) or NOAC for > 4 weeks prior to ablation
Patients must be able and willing to provide written informed consent to participate in the clinical trial
Maximum of 50% of patients (13 patients) in persistent AF < 12 months (>30% of long-standing persistent AF ≥ 12 months)
Being affiliated to a social security scheme or beneficiary of such a scheme
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Saint Joseph Marseille | Marseille | 13008 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |