Clinical and Healthcare Economic OutcoMes From ReAl-worlD Use in Europe of an AI Software During AF Ablation

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Hôpital Saint-Joseph
RECRUITING
Marseille
Hôpital Privé Jacques Cartier
RECRUITING
Massy
Polyclinique Saint George
NOT_YET_RECRUITING
Nice
Centre Cardiologique du Nord
RECRUITING
Saint-denis
Clinique Rhéna
RECRUITING
Strasbourg
Clinique Pasteur
RECRUITING
Toulouse
Germany
German Heart Center Munich
RECRUITING
München
Contact Information
Primary
Paola MILPIED
paola.milpied@volta-medical.com
+33768025499
Backup
Alexandra SANS
alexandra.sans@volta-medical.com
Time Frame
Start Date: 2023-10-27
Estimated Completion Date: 2027-04-27
Participants
Target number of participants: 150
Related Therapeutic Areas
Sponsors
Collaborators: Fortrea
Leads: Volta Medical

This content was sourced from clinicaltrials.gov