Status:
RECRUITING
Clinical and Healthcare Economic OutcoMes From ReAl-worlD Use in Europe of an AI Software During AF Ablation
Lead Sponsor:
Volta Medical
Collaborating Sponsors:
Fortrea
Conditions:
Atrial Fibrillation
Atrial Arrhythmia
Eligibility:
All Genders
18+ years
Brief Summary
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 V...
Detailed Description
All patients enrolled are treated for atrial fibrillation/tachycardia via a catheter ablation procedure using Volta Medical AI software during the mapping phase to identify areas of interest specific ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Enrollment in an investigational study evaluating another device, biologic, or drug.
Key Trial Info
Start Date :
October 27 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 27 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06083012
Start Date
October 27 2023
End Date
April 27 2027
Last Update
October 8 2024
Active Locations (7)
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1
Hôpital Saint-Joseph
Marseille, France, 13008
2
Hôpital Privé Jacques Cartier
Massy, France, 91300
3
Polyclinique Saint George
Nice, France, 06105
4
Centre Cardiologique du Nord
Saint-Denis, France, 93207