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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

278 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-06

Study Completion Date

2027-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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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).

Volta AF-Xplorer

Intervention Type DEVICE

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

Dispersion ablation + PVI

Intervention Type PROCEDURE

TAILORED-AF index procedure: Dispersion ablation + PVI

Active Comparator: Anatomical

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

PVI

Intervention Type PROCEDURE

TAILORED-AF index procedure: PVI only

Interventions

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Volta AF-Xplorer

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

Intervention Type DEVICE

Dispersion ablation + PVI

TAILORED-AF index procedure: Dispersion ablation + PVI

Intervention Type PROCEDURE

PVI

TAILORED-AF index procedure: PVI only

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabel DEISENHOFER, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Muenchen

Locations

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