VOLta Medical AI-software in REal-World During AF Ablation
Recruiting · NCT07621055 · Observational (researchers observe without assigning treatment) · Lead sponsor: Volta Medical
View the official record on ClinicalTrials.gov →Interventions studied
Cardiac mapping
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
3 locations listed.
- Hôpital Saint-Joseph Marseille - Marseille, France
- Centre Cardiologique du Nord - Saint-Denis, France
- Clinique Rhéna - Strasbourg, France