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

March 10, 2025 updated by: Volta Medical
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

278

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bron, France, 69677
        • Not yet recruiting
        • CHU Lyon, Hôpital Louis Pradel
        • Contact:
          • Francis Bessière, MD
      • Clermont-Ferrand, France, 63050
        • Not yet recruiting
        • Pôle Santé République
        • Contact:
          • Antoine Roux, MD
      • Lomme, France, 59462
        • Not yet recruiting
        • Hôpital Saint Philibert
        • Contact:
          • Yves Guyomar, MD
      • Marseille, France, 13008
        • Recruiting
        • Hôpital Saint-Joseph Marseille
        • Contact:
          • Edouard Gitenay, MD
      • Massy, France, 91300
        • Not yet recruiting
        • Hopital Prive Jacques Cartier
        • Contact:
          • Jérôme Horvilleur, MD
      • Nantes, France, 44277
        • Not yet recruiting
        • Hopital prive du Confluent
        • Contact:
          • Sélim Abbey, MD
      • Nice, France, 06105
        • Not yet recruiting
        • Polyclinique Saint George
        • Contact:
          • Guillaume Théodore, MD
      • Saint-Denis, France, 93207
        • Not yet recruiting
        • Centre Cardiologique du Nord
        • Contact:
          • Antoine Lepillier, MD
      • Strasbourg, France, 67000
        • Not yet recruiting
        • Clinique Rhéna
        • Contact:
          • Babé BAKOUBOULA, MD
      • Toulouse, France, 31076
        • Not yet recruiting
        • Clinique Pasteur
        • Contact:
          • Jean-Paul Albenque, MD
      • Vandœuvre-lès-Nancy, France, 54500
        • Not yet recruiting
        • CHRU Nancy, Institut Lorrain du coeur et des vaisseaux
        • Contact:
          • Christian De Chillou, MD
  • Germany
      • Coburg, Germany, 96450
        • Not yet recruiting
        • Klinikum Coburg
        • Contact:
          • Mathias Forkmann, MD
      • Munich, Germany, 80636
        • Not yet recruiting
        • German Heart Center
        • Contact:
          • Isabel Deisenhofer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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-Xplorer
Dispersion ablation strategy guided by Volta Medical AI-software targeting areas of spatiotemporal dispersed electrograms
Procedure: Dispersion ablation + PVI
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.
Procedure: PVI
TAILORED-AF index procedure: PVI only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term freedom from documented atrial fibrillation (AF) after one ablation procedure
Time Frame: 60 months
Long-term freedom from documented AF episodes > 30 seconds, with or without antiarrhythmic drugs (AADs), after a single index ablation procedure.
60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term freedom from documented AF/AT after one or two ablation procedures
Time Frame: 60 months
Long-term freedom from documented AF and Atrial Tachycardia (AT) episodes > 30 seconds, after one or two procedures, with or without AADs
60 months
Long-term freedom from documented AF/AT after one ablation procedure
Time Frame: 60 months
Long-term freedom from documented AF/AT episodes > 30 seconds, after one procedure, with or without AADs
60 months
Heath Economics - Average Number of Ablation Procedures per patient
Time Frame: 60 months
To determine how the number of repeat ablation procedures in addition to the index procedure impacts health care costs.
60 months
Heath Economics - Average Number of Hospitalizations per patient
Time Frame: 60 months
To determine how the number of hospitalizations post-ablation index procedure impacts health care costs.
60 months
Heath Economics - Average Number of Cardioversions per patient
Time Frame: 60 months
To determine how the number of cardioversions post-ablation index procedure affects health care costs.
60 months
Heath Economics - Quality of Life Progression (AFEQT Score)
Time Frame: 60 months

To determine how the quality of life progression after the ablation index procedure (measured with the Atrial Fibrillation Effect on Quality of Life Questionnaire AFEQT) impacts health care costs.

AFEQT score ranges from 0 to 100, with higher scores indicating better quality of life.
60 months
Heath Economics - Quality of Life Progression (SF-36 Score)
Time Frame: 60 months

To determine how the Quality of life progression after the ablation index procedure (measured with the 36-Item Short Form Health Survey SF-36) impacts health care costs.

The SF-36 consists of eight domains measuring physical and mental health, with scores ranging from 0 to 100 (higher scores indicate better quality of life).
60 months
Heath Economics - Proportion of Patients Under AAD
Time Frame: 60 months
To determine how the proportion of patients under antiarrhythmic drugs (AAD) impacts health care costs.
60 months
Incidence of complications (safety composite endpoint)
Time Frame: 60 months

Incidence of complications: death, cerebrovascular events, or serious treatment-related adverse event at long-term.

NOTE: In addition, each component of the composite endpoint will be individually assessed.
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Volta Medical

Investigators

  • Principal Investigator: Isabel DEISENHOFER, MD, Deutsches Herzzentrum Muenchen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 31, 2025

First Submitted That Met QC Criteria

February 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIPL-01-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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