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Atrial FibrillationDISPLAY-AFNCT07807423

Use of Volta Medical AI-software During Atrial Fibrillation Ablation to Identify Patients Who May Need More Than Pulmonary Vein Isolation.

A study testing Complete biatrial mapping in people with Atrial Fibrillation, run by Volta Medical at 5 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

DISPLAY-AF is a prospective, multicenter, single-arm post-market clinical follow-up investigation designed to evaluate whether spatiotemporal dispersion areas identified by the Volta AF-Xplorer II artificial intelligence (AI) software can predict recurrence of atrial arrhythmias after pulmonary vein isolation… 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?
Complete biatrial mapping
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
5 sitesFrance
Study dates
22 Sep 2026to Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Patient aged 18 years or older.
  • De novo patient candidate for catheter ablation of persistent atrial fibrillation (AF episode >7 days).
  • Continuous anticoagulation for more than 4 weeks before ablation.
  • Patient giving his signed consent form to participate in the clinical study.
  • Patient affiliated to the French social security.

Who cannot join

  • Contraindication to AF/AT catheter ablation.
  • Major bleeding disorder.
  • Contraindication to anticoagulation (Heparin, Warfarin or NOAC…) or lack of anticoagulation for 4 weeks prior to the procedure.
  • Presence of a LA thrombus on transesophageal echocardiography (TEE) prior to the procedure.
  • History of blood clotting or bleeding abnormalities
  • Acute illness or active systemic infection or sepsis
Show all 17Show fewer
  • Any cardiac surgery within the past 2 months (60 days) (includes PCI)
  • Myocardial infarction within the past 2 months (60 days)
  • Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
  • Diagnosed atrial myxoma
  • Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter
  • Documented thromboembolic event (including TIA) within the past 12 months (365 days)
  • Unstable angina within the past month
  • 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)
  • Patient who is or could potentially be pregnant.
  • Person deprived of liberty or under guardianship.
  • Patient's refusal to participate in the study.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Paola MILPIED contact

+33768025499

paola.milpied@volta-medical.com

Cécile BIELMANN contact

cecile.bielmann@volta-medical.com

5 sites in 1 country

France5 sites, 5 recruiting

  • Clinique Rhône Durance

    Avignon, 84000

    Francois-Xavier HAGER, MD

    Not yet recruiting

  • Hôpital Cardiologique Louis Pradel - HCL

    Bron, 69677

    Francis BESSIERE, MD

    Not yet recruiting

  • CHU Dijon

    Dijon, 21079

    Charles GUENANCIA, MD

    Not yet recruiting

  • Hôpital Saint-Joseph Marseille

    Marseille, 13008

    Clément BARS, MD

    Recruiting

  • Clinique Rhéna

    Strasbourg, 67000

    Babé BAKOUBOULA, MD

    Not yet recruiting

Other trials in France

About this study

Official title: Relationship Between Spatiotemporal Dispersion Areas DISPLAYed by Volta Medical Artificial Intelligence Software and Atrial Arrhythmia Recurrence After Pulmonary Vein Isolation-Only Ablation for Persistent Atrial Fibrillation

DISPLAY-AF is a prospective, multicenter, single-arm post-market clinical follow-up investigation designed to evaluate whether spatiotemporal dispersion areas identified by the Volta AF-Xplorer II artificial intelligence (AI) software can predict recurrence of atrial arrhythmias after pulmonary vein isolation (PVI)-only ablation in patients with persistent atrial fibrillation.

Read the detailed description

Atrial fibrillation (AF) recurrence remains frequent after pulmonary vein isolation (PVI), particularly in patients with persistent AF, suggesting a role for non-pulmonary vein arrhythmogenic substrates. Spatiotemporal dispersion of intracardiac electrograms has been associated with AF maintenance and may provide insights into mechanisms underlying treatment failure.

Volta AF-Xplorer II is a CE-marked artificial intelligence-based software that assists electrophysiologists by identifying and displaying areas exhibiting spatiotemporal dispersion during AF ablation procedures. Previous studies have demonstrated the feasibility and clinical relevance of AI-guided dispersion analysis and ablation strategies in patients with persistent AF.

The DISPLAY-AF study was designed to investigate the relationship between spatiotemporal dispersion characteristics detected by Volta AF-Xplorer II and atrial arrhythmia recurrence following a standard PVI-only ablation strategy in patients undergoing de novo ablation for persistent AF. The study also aims to further characterize the distribution and evolution of dispersion patterns during AF ablation procedures.

Participants will be followed for 12 months after the index procedure, with scheduled visits at 3, 6, and 12 months. Follow-up assessments include ECGs, Holter monitoring, recurrence assessment, quality-of-life evaluation using the EQ-5D-3L questionnaire, symptom evaluation, medication review, and adverse event monitoring.

Being tested
Complete biatrial mapping
Keywords
Volta AF-Xplorer II, Artificial Intelligence, Cardiac ablation, Medical Device, Software, Volta Medical, Spatiotemporal Dispersion, extra-PV substrate, PVI non-responder
Medical subject headings
Atrial Fibrillation

What participants receive

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

  • Complete biatrial mappingDevice

    All enrolled patients undergo catheter ablation for persistent atrial fibrillation. During the mapping phases of the procedure, the CE-marked Volta AF-Xplorer II artificial intelligence software is used according to its intended use to identify and display areas exhibiting spatiotemporal dispersion.

    Complete biatrial mappings of spatiotemporal dispersion areas are performed before and after Pulmonary Vein Isolation using Volta AF-Xplorer II connected to a compatible electroanatomical 3D mapping system (EnSite or CARTO).

    For the abation, Pulmonary vein isolation (PVI) is performed using radiofrequency (RF) or pulsed field ablation (PFA), consisting of the creation of contiguous circumferential lesions around each pulmonary vein antrum.

    The main phases of the ablation procedure are:

    • 1st complete biatrial mapping
    • Ablation (PVI only)
    • 2nd complete biatrial mapping
Study groups in NCT07807423
Study groupRoleWhat they receive
Intervention: Complete biatrial mapping before and after PVI using Volta AF-Xplorer IIExperimentalNot described
Receives: Device: Complete biatrial mapping

What is being measured

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

  1. PVI non-responder rate defined as the proportion of patients experiencing atrial arrhythmia recurrence (documented AF/AT episode ≥30 seconds) within 12 months following a PVI-only ablation procedure according to the extra-PV/Perivenous Dispersion ratio.

    Measured: 12 months

Secondary outcomes (5)

  1. PVI non-responder rate per type of atrial arrythmia recurrence within 12 months following a PVI-only ablation procedure according to the extra-PV/Perivenous Dispersion ratio.

    Measured: 12 months

  2. PVI non-responder rate within 12 months following a PVI-only ablation procedure according to the dispersion localization.

    Measured: 12 months

  3. Volta AF-Xplorer II-related Serious Incident rate.

    Measured: 12 months

  4. Spatio-temporal dispersion extent and distribution obtained before and after PVI (LA, RA, biatrial)

    Measured: 12 months

  5. Spatio-temporal dispersion areas (extent and distribution) between index and repeat ablation procedures in the study

    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 Sep 2026
  2. Study start22 Sep 2026
  3. Primary completionFeb 2028 (estimated)
  4. Study completionFeb 2028 (estimated)

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
125 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07807423
Sponsor's protocol ID
CLIPL-05-003
Acronym
DISPLAY-AF
Status last verified
Sep 2026
First submitted
1 Sep 2026
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • Hummel JD, Zei PC, Metzl M, Deisenhofer I, Rashid H, Morales G, Horvilleur J, Mountantonakis S, Albenque JP, Vasaiwala S, De Potter T, Lador A, Magnano A, Chicos AB, Silverstein J, Guerrero D, Beguin S, El-Benna A, Nguyen-Tu MS, Lotteau S, Milpied P, Durdez TM, Kalifa J, Bars C, Seitz J, D'Souza B, Cooper DH, Nair D, Lakkireddy D. Reablation of atrial fibrillation targeting electrogram dispersion in patients with isolated veins: The RESTART trial. Heart Rhythm. 2026 May;23(5):1083-1090. doi: 10.1016/j.hrthm.2026.01.042. Epub 2026 Feb 2.

    PubMed 41638617

  • 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

  • Deisenhofer I, Seitz J, Lotteau S, Albenque JP, Busch S, Nguyen-Tu MS, Dayot A, Dalmau M, Leukovich H, Bars C, De Potter T, de Chillou C, Goldbarg S, Appetiti A, Milpied P, Durdez TM, Hummel JD, Kalifa J. Targetable atrial tachycardias after artificial intelligence-guided ablation of persistent atrial fibrillation. Heart Rhythm. 2026 Mar;23(3):e357-e367. doi: 10.1016/j.hrthm.2025.11.018. Epub 2025 Nov 14.

    PubMed 41242590

Questions about this trial

What is this clinical trial studying?

A study testing Complete biatrial mapping in people with Atrial Fibrillation, run by Volta Medical at 5 sites in France.

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 5 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Paola MILPIED (+33768025499, paola.milpied@volta-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PVI non-responder rate defined as the proportion of patients experiencing atrial arrhythmia recurrence (documented AF/AT episode ≥30 seconds) within 12 months following a PVI-only ablation procedure according to the extra-PV/Perivenous Dispersion ratio. (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 NCT07807423, 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 25 Sep 2026.

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