NCT06083012Active, not recruiting
Clinical and Healthcare Economic OutcoMes From ReAl-worlD Use in Europe of an AI Software During AF Ablation
Source: ClinicalTrials.gov · Last updated 15 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 186 (actual)
- First submitted
- 9 Oct 2023
- Start date
- 27 Oct 2023
- Primary completion date
- 27 Apr 2027
- Lead sponsor
- Volta Medical
- Diseases
- Atrial fibrillation
- NCT number
- NCT06083012
What you commit to
- Study type: Observational
- Participants enrolled: 186
- From 27 Oct 2023 to the primary completion date, 27 Apr 2027
- 7 sites in 2 countries
- 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 an investigational study evaluating another device, biologic, or drug.
Other
- Contraindication to AF/AT catheter ablation.
- 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 VX1 or Volta AF-Xplorer or 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 (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| German Heart Center Munich Coordinator of this site? Confirm its status | München | Germany | Unknown status |
| Hôpital Saint Joseph Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Hôpital Privé Jacques Cartier Coordinator of this site? Confirm its status | Massy | France | Unknown status |
| Polyclinique Saint George Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Centre Cardiologique du Nord Coordinator of this site? Confirm its status | Saint-Denis | France | Unknown status |
| Clinique Rhéna Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| Clinique Pasteur Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.