Observing the use of AI software during heart ablation procedures in Europe
Clinical and Healthcare Economic OutcoMes From ReAl-worlD Use in Europe of an AI Software During AF Ablation
This study is testing how safe and effective it is to use AI software during heart procedures for people with atrial fibrillation and atrial tachycardia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Volta Medical Industry-sponsored |
| Locations | 7 sites (Marseille and 6 other locations) |
| Trial ID | NCT06083012 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and performance outcomes of using Volta Medical's AI software during catheter ablation for atrial fibrillation and atrial tachycardia in real-world clinical settings. Patients aged 18 and older who are candidates for this procedure will be treated using the AI software to guide the mapping phase, while the ablation approach will be determined by the operator's standard practice. The study will collect data on adverse events, recurrence of arrhythmias, and quality of life over a 24-month follow-up period, allowing for a comprehensive assessment of both clinical and economic outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled for catheter ablation to treat paroxysmal or persistent atrial fibrillation or atrial tachycardia.
Not a fit: Patients who are contraindicated for catheter ablation or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness and safety of atrial fibrillation ablation procedures through the integration of AI technology.
How similar studies have performed: While the use of AI in medical procedures is gaining traction, this specific approach in the context of atrial fibrillation ablation is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Marseille and 6 other locations
- Hôpital Saint-Joseph — Marseille, France (Recruiting)
- Hôpital Privé Jacques Cartier — Massy, France (Recruiting)
- Polyclinique Saint George — Nice, France (Not_yet_recruiting)
- Centre Cardiologique du Nord — Saint-Denis, France (Recruiting)
- Clinique Rhéna — Strasbourg, France (Recruiting)
- Clinique Pasteur — Toulouse, France (Recruiting)
- German Heart Center Munich — München, Germany (Recruiting)
Study contacts
- Principal investigator: Julien SEITZ, MD — Hôpital Saint Joseph Marseille
- Study coordinator: Paola MILPIED
- Email: paola.milpied@volta-medical.com
- Phone: +33768025499
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.