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

Plain Language Summary

Simplified for easier understanding

This long-term study is comparing two strategies for ablation (a procedure using heat or cold to destroy small areas of heart tissue that cause irregular rhythms) in people with atrial fibrillation (AFib): a tailored approach based on the individual's specific triggers versus a standard anatomical approach. **You may be eligible if...** - You are 18 or older - You have symptomatic atrial fibrillation that has not been controlled by medications - This is your first ablation procedure for AFib - You are in acceptable health for the procedure **You may NOT be eligible if...** - You have had a previous ablation for atrial fibrillation - You have severe structural heart disease (such as severe valve disease) - You have a blood clot in the left atrium of your heart - You have recently had a stroke or heart attack Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

View Full Details on ClinicalTrials.gov

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NCT06825104


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