NCT06825104

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Mar 2025

Typical duration for all trials

Geographic Reach
2 countries

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Mar 2025Dec 2027

First Submitted

Initial submission to the registry

January 31, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

March 6, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

2.8 years

First QC Date

January 31, 2025

Last Update Submit

March 10, 2025

Conditions

Atrial Fibrillation

Keywords

Artificial IntelligenceVX1Volta AF-XplorerMedical DeviceCardiac DispersionVolta MedicalSoftware

Outcome Measures

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.

    60 months

Secondary Outcomes (9)

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

    60 months

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

    60 months

  • Heath Economics - Average Number of Ablation Procedures per patient

    60 months

  • Heath Economics - Average Number of Hospitalizations per patient

    60 months

  • Heath Economics - Average Number of Cardioversions per patient

    60 months

  • +4 more secondary outcomes

Study Arms (2)

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).

Device: Volta AF-XplorerProcedure: Dispersion ablation + PVI

Active Comparator: Anatomical

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

Procedure: PVI

Interventions

Volta AF-XplorerDEVICE

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

Experimental: Tailored
Dispersion ablation + PVIPROCEDURE

TAILORED-AF index procedure: Dispersion ablation + PVI

Experimental: Tailored
PVIPROCEDURE

TAILORED-AF index procedure: PVI only

Active Comparator: Anatomical

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

CHU Lyon, Hôpital Louis Pradel

Bron, 69677, France

NOT YET RECRUITING

Pôle Santé République

Clermont-Ferrand, 63050, France

NOT YET RECRUITING

Hôpital Saint Philibert

Lomme, 59462, France

NOT YET RECRUITING

Hôpital Saint-Joseph Marseille

Marseille, 13008, France

RECRUITING

Hôpital Privé Jacques Cartier

Massy, 91300, France

NOT YET RECRUITING

Hôpital Privé du Confluent

Nantes, 44277, France

NOT YET RECRUITING

Polyclinique Saint George

Nice, 06105, France

NOT YET RECRUITING

Centre Cardiologique du Nord

Saint-Denis, 93207, France

NOT YET RECRUITING

Clinique Rhéna

Strasbourg, 67000, France

NOT YET RECRUITING

Clinique Pasteur

Toulouse, 31076, France

NOT YET RECRUITING

CHRU Nancy, Institut Lorrain du coeur et des vaisseaux

Vandœuvre-lès-Nancy, 54500, France

NOT YET RECRUITING

Klinikum Coburg

Coburg, 96450, Germany

NOT YET RECRUITING

German Heart Center

Munich, 80636, Germany

NOT YET RECRUITING

Related Publications (3)

  • Deisenhofer I, Albenque JP, Busch S, Gitenay E, Mountantonakis SE, Roux A, Horvilleur J, Bakouboula B, Oza S, Abbey S, Theodore G, Lepillier A, Guyomar Y, Bessiere F, Jan Smit J, Mohr Durdez T, Milpied P, Appetiti A, Guerrero D, De Potter T, De Chillou C, Goldbarg S, Verma A, Hummel JD; TAILORED-AF Investigators. Artificial intelligence for individualized treatment of persistent atrial fibrillation: a randomized controlled trial. Nat Med. 2025 Apr;31(4):1286-1293. doi: 10.1038/s41591-025-03517-w. Epub 2025 Feb 14.

    PMID: 39953289BACKGROUND

  • Seitz J, Bars C, Theodore G, Beurtheret S, Lellouche N, Bremondy M, Ferracci A, Faure J, Penaranda G, Yamazaki M, Avula UM, Curel L, Siame S, Berenfeld O, Pisapia A, Kalifa J. AF Ablation Guided by Spatiotemporal Electrogram Dispersion Without Pulmonary Vein Isolation: A Wholly Patient-Tailored Approach. J Am Coll Cardiol. 2017 Jan 24;69(3):303-321. doi: 10.1016/j.jacc.2016.10.065.

    PMID: 28104073BACKGROUND

  • Seitz J, Durdez TM, Albenque JP, Pisapia A, Gitenay E, Durand C, Monteau J, Moubarak G, Theodore G, Lepillier A, Zhao A, Bremondy M, Maluski A, Cauchemez B, Combes S, Guyomar Y, Heuls S, Thomas O, Penaranda G, Siame S, Appetiti A, Milpied P, Bars C, Kalifa J. Artificial intelligence software standardizes electrogram-based ablation outcome for persistent atrial fibrillation. J Cardiovasc Electrophysiol. 2022 Nov;33(11):2250-2260. doi: 10.1111/jce.15657. Epub 2022 Sep 18.

    PMID: 35989543BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Isabel DEISENHOFER, MD

    Deutsches Herzzentrum Muenchen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola MILPIED

CONTACT

(0)768025499paola.milpied@volta-medical.com

Cecile BIELMANN

CONTACT

cecile.bielmann@volta-medical.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2025

First Posted

February 13, 2025

Study Start

March 6, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(11)DE(2)