Arrhythmias, Cardiac, Atrial Arrhythmia, Atrial Fibrillation
Conditions
Keywords
Volta AF-Xplorer II, Artificial Intelligence, Cardiac ablation, Medical Device, Software, Volta Medical, Atrial Arrhythmia
Brief summary
This PMCF study "VOLTAIRE-AF" will allow to observe acute and long-term safety and performance outcomes of the last generation of Volta Medical AI software (Volta AF-Xplorer II) during AF ablation using next-generation mapping and ablation technologies over a 24-month follow-up and in "real life"clinical practice, without any imposed clinical workflow.
Detailed description
All patients enrolled are treated for atrial fibrillation/tachycardia via a catheter ablation procedure using the last generation of Volta Medical AI software (Volta AF-Xplorer II) during the mapping phase to identify areas of interest specific to the patient. The ablation approach is free and chosen by the operator according to standard practice. Intraoperative and postoperative follow-up will be performed as in routine clinical practice during AF ablation procedures: hospitalization for ablation procedure and standard postoperative quarterly visits (at 3 months, at 6 months and/or 9 months as per the study investigator's Standard Of Care) then annual visits up to 24 months post-ablation. Adverse Events, recurrences of atrial arrhythmia, Heart Failure related symptom score ("NYHA") and AF related symptoms (EHRA score) are collected from the patient's enrollment until the patient's study termination. A quality-of-life questionnaire related to general health (EQ-5D-3L) is collected during the preoperative visit and at least during annual follow-up visits. The patient's study-termination corresponds to the last annual visit at 24 months post-ablation index.
Interventions
DEVICECardiac mapping
All patients enrolled are treated for their atrial fibrillation/tachycardia via a catheter ablation procedure using the last generation of Volta Medical AI software (Volta AF-Xplorer II, used in accordance with its approved indication as per of its IFU) during the mapping phase to identify areas of interest specific to the patient. The ablation approach is free and chosen by the operator according to his standard practice. The two main phases of the ablation procedure are: * 3D mapping of the atria and location of areas of interest; * Catheter ablation at the operator's discretion.
Sponsors
Volta Medical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient aged 18 years or older. 2. Patient candidate for catheter ablation to treat paroxysmal or persistent atrial fibrillation, atrial tachycardia, de novo or after one or several previous ablation procedures, and for which the investigator considers using Volta AF-Xplorer II. 3. Patient able and willing to provide written informed consent to participate in the study. 4. Only for France: Patient affiliated to the French social security system.
Exclusion criteria
1. Contraindication to AF/AT catheter ablation using RF and/or PFA. 2. Patient who is or could potentially be pregnant. 3. Person deprived of liberty or under guardianship. 4. Person unable to undergo a medical monitoring for geographical, social or psychological reasons. 5. Patient's refusal to participate in the study. 6. Enrollment in a premarket clinical study evaluating device, drug or biologic product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from clinically significant AF or atrial arrhythmia recurrence, after one or multiple ablation procedures, with or without antiarrhythmic drugs, at 12 and 24 months. | 24 months | An Atrial Arrhythmia episode (AF/AFL/AT ≥ 30s) will be determined to be clinically significant if it results in an unexpected treatment change (e.g. new anti-arrhythmic drug or higher dose of AAD, repeat ablation procedure, DC cardioversion), or if it is accompanied by worsening of symptoms related to AF, considering a standard 3-month blanking period. |
| Volta AF-Xplorer II-related Serious Incident rate | 24 months | — |
| Ablation procedure-related Serious Adverse Event rate | 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression of Quality-Of-Life score ("EQ-5D-3L") during the study (at inclusion, at quarterly visits, at 12 months and at 24 months). | 24 months |
| Progression of the AF related symptom score ("EHRA") during the study (at inclusion, at quarterly visits, at 12 months and at 24 months). | 24 months |
| Progression of the Heart Failure related symptom score ("NYHA") during the study (at inclusion, at quarterly visits, at 12 months and at 24 months). | 24 months |
| Hospitalization rate during the post-ablation follow-up period. | 24 months |
| Serious Adverse Event rate during the post-ablation follow-up period. | 24 months |
| Average number of ablation procedures per patient up to 24 months follow-up. | 24 months |
| Average number of cardioversions per patient up to 24 months follow-up | 24 months |
| Progression of patient proportion under antiarrhythmic drugs and/or anticoagulant treatments during the study. | 24 months |
| Health economics analysis including QALY metric | 24 months |
Countries
France
Contacts
CONTACTPaola MILPIED
CONTACTCecile BIELMANN
PRINCIPAL_INVESTIGATORClément BARS, MD
Hôpital Saint Joseph Marseille
Outcome results
None listed