NCT04702451

Brief Summary

Atrial Fibrillation (AF) ablation is typically performed in predefined anatomic regions of the left atrium without attempting to identify patient-specific areas of interest. This procedure is referred to as Pulmonary Vein Isolation (PVI). The hypothesis in this Study is that a tailored ablation strategy targeting areas of spatio-temporal dispersion in combination with PVI is superior to an anatomical ablation strategy targeting PVI alone for the treatment of persistent AF.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
377

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
5 countries

26 active sites

Status
completed

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

First Submitted

Initial submission to the registry

January 7, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

February 12, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

September 12, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

2.9 years

First QC Date

January 7, 2021

Results QC Date

March 25, 2025

Last Update Submit

September 11, 2025

Conditions

Atrial Fibrillation

Keywords

Persistent Atrial FibrillationCatheter AblationElectrogram dispersion

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Free From Documented AF After One Ablation Procedure

    Freedom from documented AF episodes \> 30 seconds, with or without anti-arrhythmic drugs (AADs), 12 months after a single index ablation procedure

    12 months

Secondary Outcomes (3)

  • Number of Participants Free From Documented AF/AT After One or Two Ablation Procedures

    12 months

  • Number of Participants Free From Documented AF/AT After One Ablation Procedure

    12 months

  • Number of Participants With Complications (Safety Composite Endpoint)

    12 months

Study Arms (2)

Tailored

EXPERIMENTAL

Tailored ablation strategy

Procedure: Dispersion ablation + PVIDevice: VX1

Anatomical

ACTIVE COMPARATOR

Anatomical ablation strategy

Procedure: PVI

Interventions

Dispersion ablation + PVIPROCEDURE

Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation

Tailored
VX1DEVICE

VX1-based dispersion mapping

Tailored
PVIPROCEDURE

Pulmonary vein antrum isolation

Anatomical

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years of age or older candidates for a first AF ablation
  • Symptomatic AF, refractory to at least one antiarrhythmic medication
  • Persistent or long-standing persistent AF with documentation of (ECG, Holter, physician's letter): AF duration of ≥ 3 months and ≤ 5 years (≥ 3 months and \< 1 year in the United States) or 1 effective cardioversion followed by AF recurrence lasting ≥ 3 months
  • Continuous anticoagulation with warfarin (INR 2-3) or NOAC for \> 4 weeks prior to ablation
  • Patients must be able and willing to provide written informed consent to participate in the clinical trial
  • At least 60% of patients (224 patients) in persistent AF ≥ 6 months including at least 15% (56 patients) of long-standing persistent AF ≥ 12 months

You may not qualify if:

  • Paroxysmal and short-standing AF \< 3 months
  • Long-standing persistent AF \> 5 years (≥ 1 year in the United States)
  • ≥ 2 previous ineffective cardioversion sessions in case of undetermined AF duration
  • Severe obesity (BMI \> 40)
  • Very dilated Left Atrium (LA)(e.g. LA diameter \> 60 mm and/or LA surface \> 40 cm2 determined by 2D echocardiography)
  • Patients with AF secondary to an obvious reversible cause
  • LA thrombus on Transesophageal Echocardiography (TEE) or CT Scan prior to procedure
  • Contraindications to anticoagulation (heparin, warfarin or NOAC)
  • Patients who are or may potentially be pregnant
  • Previous surgical or catheter ablation for AF
  • Any cardiac surgery within the past 2 months (60 days) (includes PCI)
  • Myocardial infarction within the past 2 months (60 days)
  • Previous atrioventricular valve surgery
  • History of blood clotting or bleeding abnormalities
  • Documented arterial thromboembolic event (including TIA) within the past 12 months (365 days)
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

Ascension St. Vincent's

Jacksonville, Florida, 32204, United States

Location

Washington University

St Louis, Missouri, 63130, United States

Location

Northwell Health

New York, New York, 10075, United States

Location

New York Presbyterian Queens Hospital

Queens, New York, 11355, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Inova Fairfax

Falls Church, Virginia, 22042, United States

Location

OLV Aalst

Aalst, 9300, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Pôle Santé République

Clermont-Ferrand, 63000, France

Location

Hôpital Saint Philibert

Lomme, 59462, France

Location

Hôpital Louis Pradel - Hospices Civils de Lyon

Lyon, 69677, France

Location

Hôpital Saint-Joseph

Marseille, 13008, France

Location

Hôpital Privé Jacques Cartier

Massy, 91300, France

Location

Hôpital Privé du Confluent

Nantes, 44200, France

Location

Clinique Saint George

Nice, 06105, France

Location

Centre Cardiologique du Nord

Saint-Denis, 93200, France

Location

Clinique Rhéna

Strasbourg, 67000, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

CHRU Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

Klinikum Coburg

Coburg, 96450, Germany

Location

Städtisches Klinikum Karlsruhe

Karlsruhe, 76133, Germany

Location

Deutsches Herzzentrum München

München, 80636, Germany

Location

OLVG Amsterdam

Amsterdam, 1091, Netherlands

Location

Isala Hartcentrum Zwolle

Zwolle, 8025, Netherlands

Location

Related Publications (4)

  • 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

  • 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: 39953289RESULT

  • Deisenhofer I, Seitz J, Nguyen-Tu MS, Lotteau S, Bars C, Albenque JP, Busch S, Gitenay E, Mountantonakis S, Roux A, Horvilleur J, Bakouboula B, Oza S, Abbey S, Theodore G, Lepillier A, Guyomar Y, Bessiere F, Smit JJ, Rajendra A, Cooper DH, Rashid H, De Potter T, De Chillou C, Goldbarg S, Verma A, Morales G, Milpied P, Hummel JD, Kalifa J. Women with persistent atrial fibrillation need more than pulmonary vein isolation: personalised extra-pulmonary vein ablation strategy vs. pulmonary vein isolation alone in the TAILORED-AF trial. Europace. 2025 Oct 31;27(11):euaf281. doi: 10.1093/europace/euaf281.

    PMID: 41311304DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Paola Milpied
Organization
Volta Medical
paola.milpied@volta-medical.com
+33768025499

Study Officials

  • Isabel Deisenhofer, MD

    Deutsches Herzzentrum Muenchen

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 8, 2021

Study Start

February 12, 2021

Primary Completion

December 27, 2023

Study Completion

December 27, 2023

Last Updated

September 12, 2025

Results First Posted

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(11)US(8)BE(2)NL(2)DE(3)