Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Procedure, Device
Study Type: Observational
SUMMARY
The TAILORED-LT study is conducted as an extension follow-up until 5 years of the initial TAILORED-AF study (NCT04702451), in order to demonstrate the long-term superiority in terms of freedom of atrial fibrillation (AF) of a tailored ablation strategy targeting areas of spatio-temporal dispersed electrograms in combination with pulmonary veins isolation (PVI) over an anatomical ablation strategy targeting PVI alone for the initial ablation procedure of persistent AF.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patient who participated in the Tailored AF study
• Patient not withdrawn during the 12-month follow-up period post-index procedure in the Tailored AF study
• Patient able and willing to provide written informed consent to participate in this extension Tailored-LT study
Locations
Other Locations
France
CHU Lyon, Hôpital Louis Pradel
NOT_YET_RECRUITING
Bron
Pôle Santé République
NOT_YET_RECRUITING
Clermont-ferrand
Hôpital Saint Philibert
NOT_YET_RECRUITING
Lomme
Hôpital Saint-Joseph Marseille
RECRUITING
Marseille
Hôpital Privé Jacques Cartier
NOT_YET_RECRUITING
Massy
Hôpital Privé du Confluent
NOT_YET_RECRUITING
Nantes
Polyclinique Saint George
NOT_YET_RECRUITING
Nice
Centre Cardiologique du Nord
NOT_YET_RECRUITING
Saint-denis
Clinique Rhéna
NOT_YET_RECRUITING
Strasbourg
Clinique Pasteur
NOT_YET_RECRUITING
Toulouse
CHRU Nancy, Institut Lorrain du coeur et des vaisseaux
NOT_YET_RECRUITING
Vandœuvre-lès-nancy
Germany
Klinikum Coburg
NOT_YET_RECRUITING
Coburg
German Heart Center
NOT_YET_RECRUITING
Munich
Contact Information
Primary
Paola MILPIED
paola.milpied@volta-medical.com
(0)768025499
Backup
Cecile BIELMANN
cecile.bielmann@volta-medical.com
Time Frame
Start Date: 2025-03-06
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 278
Treatments
Experimental: Tailored
Patients from the Tailored group in the initial study TAILORED-AF. Patients in this group underwent Tailored AF ablation, i.e. the analysis and targeting of pathological areas using Volta Medical's artificial intelligence software (Volta AF-Xplorer, formerly VX1), in addition to electrical isolation of the pulmonary veins (PVI).
Active Comparator: Anatomical
Patients from the Anatomical group in the initial study TAILORED-AF. Patients in this group underwent PVI only.
Related Therapeutic Areas
Sponsors
Leads: Volta Medical