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NCT Number: NCT06825104

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Lyon, Hôpital Louis Pradel, Bron, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Volta AF-Xplorer

Device

Dispersion ablation strategy guided by Volta Medical AI-software targeting areas of spatiotemporal dispersed electrograms

Dispersion ablation + PVI

Procedure

TAILORED-AF index procedure: Dispersion ablation + PVI

PVI

Procedure

TAILORED-AF index procedure: PVI only

Primary outcomes

  1. Long-term freedom from documented atrial fibrillation (AF) after one ablation procedure

    Time frame: 60 months

    Long-term freedom from documented AF episodes > 30 seconds, with or without antiarrhythmic drugs (AADs), after a single index ablation procedure.

Secondary outcomes

  1. Long-term freedom from documented AF/AT after one or two ablation procedures

    Time frame: 60 months

    Long-term freedom from documented AF and Atrial Tachycardia (AT) episodes > 30 seconds, after one or two procedures, with or without AADs

  2. Long-term freedom from documented AF/AT after one ablation procedure

    Time frame: 60 months

    Long-term freedom from documented AF/AT episodes > 30 seconds, after one procedure, with or without AADs

  3. Heath Economics - Average Number of Ablation Procedures per patient

    Time frame: 60 months

    To determine how the number of repeat ablation procedures in addition to the index procedure impacts health care costs.

  4. Heath Economics - Average Number of Hospitalizations per patient

    Time frame: 60 months

    To determine how the number of hospitalizations post-ablation index procedure impacts health care costs.

  5. Heath Economics - Average Number of Cardioversions per patient

    Time frame: 60 months

    To determine how the number of cardioversions post-ablation index procedure affects health care costs.

  6. Heath Economics - Quality of Life Progression (AFEQT Score)

    Time frame: 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.

  7. Heath Economics - Quality of Life Progression (SF-36 Score)

    Time frame: 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).

  8. Heath Economics - Proportion of Patients Under AAD

    Time frame: 60 months

    To determine how the proportion of patients under antiarrhythmic drugs (AAD) impacts health care costs.

  9. Incidence of complications (safety composite endpoint)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cecile BIELMANN

CONTACT

[email protected]

Paola MILPIED

CONTACT

[email protected]

(0)768025499 ext. 0033

Sponsors and collaborators

Lead sponsor

Volta Medical

Industry

Registry information

Acronym: TAILORED-LT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 13, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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