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

RecruitingOBSERVATIONAL
Enrollment

150

Participants

Timeline

Start Date

October 27, 2023

Primary Completion Date

April 27, 2027

Study Completion Date

April 27, 2027

Conditions
Atrial FibrillationAtrial ArrhythmiaArrhythmias, Cardiac
Interventions
DEVICE

Cardiac mapping

"All patients enrolled are treated for their atrial fibrillation/tachycardia via a catheter ablation procedure using VX1/Volta AF-Xplorer/Volta AF-Xplorer II software (used in accordance with its approved indication as per of its IFU) during the mapping phase to identify areas of interest specific to the patient.~The ablation approach is free and chosen by the operator according to his standard practice. The two main phases of the ablation procedure are:~* 3D mapping of the atria and location of areas of interest;~* Catheter ablation at the operator\'s discretion."

Trial Locations (7)

13008

RECRUITING

Hôpital Saint-Joseph, Marseille

31000

RECRUITING

Clinique Pasteur, Toulouse

67000

RECRUITING

Clinique Rhéna, Strasbourg

80636

RECRUITING

German Heart Center Munich, München

91300

RECRUITING

Hôpital Privé Jacques Cartier, Massy

93207

RECRUITING

Centre Cardiologique du Nord, Saint-Denis

06105

NOT_YET_RECRUITING

Polyclinique Saint George, Nice

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Fortrea

INDUSTRY

lead

Volta Medical

INDUSTRY