NCT07621055Recruiting
VOLta Medical AI-software in REal-World During AF Ablation
Real-World Experience of Volta Medical AI-software During AF Ablation Using Next-generation Mapping and Ablation Technologies
Source: ClinicalTrials.gov · Last updated 22 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 27 May 2026
- Start date
- 16 Jun 2026
- Primary completion date
- Jun 2030
- Lead sponsor
- Volta Medical
- Diseases
- Atrial fibrillation
- NCT number
- NCT07621055
What you commit to
- Study type: Observational
- Planned participants: 150
- From 16 Jun 2026 to the primary completion date, Jun 2030
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Enrollment in a premarket clinical study evaluating device, drug or biologic product.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Saint Joseph Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Cardiologique du Nord Coordinator of this site? Confirm its status | Saint-Denis | France | Not yet recruiting |
| Clinique Rhéna Coordinator of this site? Confirm its status | Strasbourg | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.