Real-World Experience of Volta Medical AI-software During AF Ablation Using Next-generation Mapping and Ablation Technologies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Volta Medical
- Enrollment
- 150
- Locations
- 3
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient aged 18 years or older.
- •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.
- •Patient able and willing to provide written informed consent to participate in the study.
- •Only for France: Patient affiliated to the French social security system.
Exclusion Criteria
- •Contraindication to AF/AT catheter ablation using RF and/or PFA.
- •Patient who is or could potentially be pregnant.
- •Person deprived of liberty or under guardianship.
- •Person unable to undergo a medical monitoring for geographical, social or psychological reasons.
- •Patient's refusal to participate in the study.
- •Enrollment in a premarket clinical study evaluating device, drug or biologic product.