RecruitingNCT06825104

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


Sponsor

Volta Medical

Enrollment

278 participants

Start Date

Mar 6, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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  • Patient not withdrawn during the 12-month follow-up period post-index procedure in the Tailored AF study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 Criteria2

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

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


Locations(13)

CHU Lyon, Hôpital Louis Pradel

Bron, France

Pôle Santé République

Clermont-Ferrand, France

Hôpital Saint Philibert

Lomme, France

Hôpital Saint-Joseph Marseille

Marseille, France

Hôpital Privé Jacques Cartier

Massy, France

Hôpital Privé du Confluent

Nantes, France

Polyclinique Saint George

Nice, France

Centre Cardiologique du Nord

Saint-Denis, France

Clinique Rhéna

Strasbourg, France

Clinique Pasteur

Toulouse, France

CHRU Nancy, Institut Lorrain du coeur et des vaisseaux

Vandœuvre-lès-Nancy, France

Klinikum Coburg

Coburg, Germany

German Heart Center

Munich, Germany

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NCT06825104


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