Health TrialsbyHealthPanel

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

ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVolta Medical

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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Patient not withdrawn during the 12-month follow-up period post-index procedure in the Tailored AF study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

Disqualifiers

Person deprived of liberty or under guardianship

Person unable to undergo a medical monitoring for geographical, social or psychological reasons

Trial population

Patients previously enrolled in TAILORED-AF study, treated for their persistent AF by an index ablation procedure and not withdrawn during the 12-month follow-up period post-index procedure.

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • Volta AF-Xplorer

    Device

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

  • Dispersion ablation + PVI

    Procedure/Surgery

    TAILORED-AF index procedure: Dispersion ablation + PVI

  • PVI

    Procedure/Surgery

    TAILORED-AF index procedure: PVI only

Treatment groups

278 Participants
are divided into 2 treatment groups
Group A: Experimental: Tailored2 interventions
Group B: Active Comparator: Anatomical1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
60 months

Secondary outcomes

1

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

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

Time frame
60 months
2

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

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

Time frame
60 months
3

Heath Economics - Average Number of Ablation Procedures per patient

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

Time frame
60 months
4

Heath Economics - Average Number of Hospitalizations per patient

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

Time frame
60 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Volta Medical

Lead sponsor

Source ClinicalTrials.gov
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