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Atrial FibrillationTailored-AFNCT04702451

Tailored vs. Anatomical Ablation Strategy for Persistent Atrial Fibrillation

A study testing Dispersion ablation + PVI, VX1 and PVI in people with Atrial Fibrillation, run by Volta Medical at 26 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Dispersion ablation + PVI, VX1 and PVI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
377 participants
Where
26 sitesin 5 countries
Study dates
12 Feb 2021to 27 Dec 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 29Show fewer
  • Inadequate anticoagulation as defined in the inclusion criteria
  • 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)
  • Rheumatic Heart Disease
  • Chronic severe Heart Failure (NYHA functional class IV and/or LVEF < 25%)
  • Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
  • Unstable angina within the past month
  • Acute illness or active systemic infection or sepsis
  • AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
  • Diagnosed atrial myxoma
  • Significant severe pulmonary disease, (e.g. patients with restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease in GOLD stage IV) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms (e.g. unstable or untreated sleep apnea)
  • Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
  • Enrollment in an investigational study evaluating another device, biologic, or drug
  • Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter
  • Life expectancy or other disease processes likely to limit survival to less than 12 months
  • Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)

Trial locations and contacts

26 sites in 5 countries.

26 sites in 5 countries

France11 sites

  • Pôle Santé République

    Clermont-Ferrand, 63000

  • Hôpital Saint Philibert

    Lomme, 59462

  • Hôpital Louis Pradel - Hospices Civils de Lyon

    Lyon, 69677

  • Hôpital Saint-Joseph

    Marseille, 13008

  • Hôpital Privé Jacques Cartier

    Massy, 91300

  • Hôpital Privé du Confluent

    Nantes, 44200

  • Clinique Saint George

    Nice, 06105

  • Centre Cardiologique du Nord

    Saint-Denis, 93200

  • Clinique Rhéna

    Strasbourg, 67000

  • Clinique Pasteur

    Toulouse, 31076

  • CHRU Nancy

    Vandœuvre-lès-Nancy, 54511

Other trials in France

United States8 sites

  • Grandview Medical Center

    Birmingham, Alabama, 35243

  • Ohio State University

    Columbus, Ohio, 43210

  • Inova Fairfax

    Falls Church, Virginia, 22042

  • Ascension St. Vincent's

    Jacksonville, Florida, 32204

  • Northwell Health

    New York, New York, 10075

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • New York Presbyterian Queens Hospital

    Queens, New York, 11355

  • Washington University

    St Louis, Missouri, 63130

Other trials in United States

Germany3 sites

  • Klinikum Coburg

    Coburg, 96450

  • Städtisches Klinikum Karlsruhe

    Karlsruhe, 76133

  • Deutsches Herzzentrum München

    München, 80636

Other trials in Germany

Belgium2 sites

  • OLV Aalst

    Aalst, 9300

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Netherlands2 sites

  • OLVG Amsterdam

    Amsterdam, 1091

  • Isala Hartcentrum Zwolle

    Zwolle, 8025

Other trials in Netherlands

About this study

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.

Being tested
Dispersion ablation + PVI, VX1, PVI
Keywords
Persistent Atrial Fibrillation, Catheter Ablation, Electrogram dispersion
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dispersion ablation + PVIProcedure or surgery

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

  • VX1Device

    VX1-based dispersion mapping

  • PVIProcedure or surgery

    Pulmonary vein antrum isolation

Study groups in NCT04702451
Study groupRoleWhat they receive
TailoredExperimentalTailored ablation strategy
Receives: Procedure: Dispersion ablation + PVI; Device: VX1
AnatomicalActive comparatorAnatomical ablation strategy
Receives: Procedure: PVI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (3)

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

    Freedom from documented AF/AT episodes > 30 seconds, after one or two procedures, with or without AADs, at 12 months

    Measured: 12 months

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

    Freedom from documented AF/AT episodes > 30 seconds, with or without AADs, 12 months after a single ablation procedure

    Measured: 12 months

  3. Number of Participants With Complications (Safety Composite Endpoint)

    Complications at 12 months: death, cerebrovascular events, or serious treatment-related adverse event

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2021 (estimated)
  2. Study start12 Feb 2021
  3. Primary completion27 Dec 2023
  4. Study completion27 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
377 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04702451
Sponsor's protocol ID
CLIPL-01-002
Acronym
Tailored-AF
Status last verified
Sep 2025
First submitted
7 Jan 2021
Last updated
12 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 28104073

  • 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.

    PubMed 35989543

  • 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.

    PubMed 39953289

  • 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.

    PubMed 41311304

Questions about this trial

What is this clinical trial studying?

A study testing Dispersion ablation + PVI, VX1 and PVI in people with Atrial Fibrillation, run by Volta Medical at 26 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in France, United States, Germany, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Free From Documented AF After One Ablation Procedure (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04702451, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.

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