Arrhythmias, Cardiac, Atrial Arrhythmia, Atrial Fibrillation
Conditions
Keywords
Artificial Intelligence, Cardiac ablation, Medical device, Software, Volta Medical, Atrial Arrhythmia, VX1, Volta AF-Xplorer, Volta AF-Xplorer II
Brief summary
The goal of this Observational Prospective Multi-center Study is to observe the acute and long-term safety and performance outcomes after spatiotemporal dispersion-based AF/AT ablation utilizing the Volta Medical AI software in real-life clinical practice, without any imposed clinical workflow. Moreover, this study will allow to collect medico-economic data related to the tailored ablation strategy guided by the Volta Medical AI software.
Detailed description
All patients enrolled are treated for atrial fibrillation/tachycardia via a catheter ablation procedure using Volta Medical AI software 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 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 VX1/Volta AF-Xplorer/Volta AF-Xplorer II software (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
Fortrea
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 VX1 or Volta AF-Xplorer or 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. 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 an investigational study evaluating another device, biologic, or drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from clinically significant AF or atrial arrhythmia recurrence, after one or multiple ablation procedures, with or without antiarrhythmic drugs, stratified by type of clinical workflow. | [24 months] |
| VX1/Volta AF-Xplorer/Volta AF-Xplorer II-related Incident rate during ablation procedure. | [24months] |
| VX1/Volta AF-Xplorer/Volta AF-Xplorer II-related Adverse Event rate. | [24months] |
Secondary
| Measure | Time frame |
|---|---|
| Serious Adverse Event rate during the post-ablation follow-up period. | [24months] |
| Average number of ablation procedures per patient up to 24 months follow-up. | [24months] |
| Progression of Quality-Of-Life score (EQ-5D-3L) during the study (at inclusion, at quarterly visits, at 12 months and at 24 months). | Preoperative; [24months] |
| Progression of patient proportion under antiarrhythmic drugs and/or anticoagulant treatments during the study. | [24months] |
| Health economics analysis including QALY metric. | [24months] |
| Average number of cardioversions per patient up to 24 months follow-up | [24months] |
| Progression of the AF related symptom score (EHRA) during the study (at inclusion, at quarterly visits, at 12 months and at 24 months). | Preoperative; [24months] |
| Hospitalization rate during the post-ablation follow-up period. | [24months] |
Countries
France, Germany
Outcome results
None listed