Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation (TAILORED-LT)

Volta Medical

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Procedure: Dispersion ablation + PVI; Procedure: PVI; Device: Volta AF-Xplorer

Study type: Observational

Funder types: Industry

Identifiers

NCT06825104

CLIPL-01-006

Details and patient eligibility

About

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.

Full description

The TAILORED-AF study demonstrated at one year's follow-up that a tailored ablation strategy guided by Volta Medical AI-software targeting areas of spatio-temporal dispersed electrograms in combination with pulmonary vein isolation (PVI) ablation is more effective to an anatomical ablation strategy targeting PVI alone (current standard of care) for the treatment of persistent atrial fibrillation (AF).

VX1 legacy device renamed Volta AF-Xplorer was used in the TAILORED-AF study in the treatment arm.

No additional treatments are specifically required in the scope of this ancillary TAILORED-LT study which aims to follow the patients previously treated in the initial TAILORED-AF study over the long-term. However, in the event of repeat procedures during the TAILORED-LT study, the choice of the ablation technique will be left to the investigator's discretion, regardless of the patient's randomization arm in the TAILORED-AF study.

The annual follow-up will be performed as in routine clinical practice post AF ablation procedures: visits at 24 months, 36 months, 48 months and 60 months post TAILORED-AF Study index procedure. It is possible that some of these annual visits cannot be completed prospectively due to time already having elapsed between the end of the subject participation in the TAILORED-AF study and the date of enrollment in the extension TAILORED-LT study. In this case, available data (among those expected by the study protocol) will be collected retrospectively.

The additional procedures related to this clinical investigation are limited to annual 24-hour Holters and to the administration of Quality Of Life questionnaires (SF-36 and AFEQT) to the patients during follow-up visits.

Enrollment: 278 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Person deprived of liberty or under guardianship
• Person unable to undergo a medical monitoring for geographical, social or psychological reasons

Trial design

278 participants in 2 patient groups

Experimental: Tailored

Description:

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).

Treatment:

Device: Volta AF-Xplorer

Procedure: Dispersion ablation + PVI

Active Comparator: Anatomical

Description:

Patients from the "Anatomical" group in the initial study TAILORED-AF. Patients in this group underwent PVI only.

Treatment:

Procedure: PVI