VOLta Medical AI-software in REal-World During AF Ablation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVolta Medical
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cardiac mapping
Treatment groups
No treatment groups listed
Locations
3Hôpital Saint-Joseph Marseille13008, Marseille France
Centre Cardiologique du Nord93207, Saint-Denis France
Clinique Rhéna67000, Strasbourg France
Sponsors and collaborators
Volta Medical
Lead sponsor
Source ClinicalTrials.gov