Atrial Fibrillation
Conditions
Keywords
Artificial Intelligence, VX1, Volta AF-Xplorer, Medical Device, Cardiac Dispersion, Volta Medical, Software
Brief 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.
Detailed 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.
Interventions
DEVICEVolta AF-Xplorer
Dispersion ablation strategy guided by Volta Medical AI-software targeting areas of spatiotemporal dispersed electrograms
PROCEDUREDispersion ablation + PVI
TAILORED-AF index procedure: Dispersion ablation + PVI
PROCEDUREPVI
TAILORED-AF index procedure: PVI only
Sponsors
Volta Medical
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term freedom from documented atrial fibrillation (AF) after one ablation procedure | 60 months | Long-term freedom from documented AF episodes \> 30 seconds, with or without antiarrhythmic drugs (AADs), after a single index ablation procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term freedom from documented AF/AT after one ablation procedure | 60 months | Long-term freedom from documented AF/AT episodes \> 30 seconds, after one procedure, with or without AADs |
| Heath Economics - Average Number of Ablation Procedures per patient | 60 months | To determine how the number of repeat ablation procedures in addition to the index procedure impacts health care costs. |
| Heath Economics - Average Number of Hospitalizations per patient | 60 months | To determine how the number of hospitalizations post-ablation index procedure impacts health care costs. |
| Heath Economics - Average Number of Cardioversions per patient | 60 months | To determine how the number of cardioversions post-ablation index procedure affects health care costs. |
| Long-term freedom from documented AF/AT after one or two ablation procedures | 60 months | Long-term freedom from documented AF and Atrial Tachycardia (AT) episodes \> 30 seconds, after one or two procedures, with or without AADs |
| Heath Economics - Quality of Life Progression (SF-36 Score) | 60 months | To determine how the Quality of life progression after the ablation index procedure (measured with the 36-Item Short Form Health Survey SF-36) impacts health care costs. The SF-36 consists of eight domains measuring physical and mental health, with scores ranging from 0 to 100 (higher scores indicate better quality of life). |
| Heath Economics - Proportion of Patients Under AAD | 60 months | To determine how the proportion of patients under antiarrhythmic drugs (AAD) impacts health care costs. |
| Incidence of complications (safety composite endpoint) | 60 months | Incidence of complications: death, cerebrovascular events, or serious treatment-related adverse event at long-term. NOTE: In addition, each component of the composite endpoint will be individually assessed. |
| Heath Economics - Quality of Life Progression (AFEQT Score) | 60 months | To determine how the quality of life progression after the ablation index procedure (measured with the Atrial Fibrillation Effect on Quality of Life Questionnaire AFEQT) impacts health care costs. AFEQT score ranges from 0 to 100, with higher scores indicating better quality of life. |
Countries
France, Germany
Contacts
Primary ContactPaola MILPIED
Backup ContactCecile BIELMANN
Outcome results
None listed