ClinicalTrials.gg
RecruitingNCT07807423DISPLAY-AFUpdated Sep 25, 2026

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

An interventional study of Complete biatrial mapping in Atrial Fibrillation, sponsored by Volta Medical. Recruiting at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Volta Medical · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Sep 25, 2026Now RecruitingSite recruiting status changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
125
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 317 studies in Atrial Fibrillation with a site in France — 63 open to participants now, 87 under way, 5 of them phase 3. Atrial Fibrillation · France.

Planned enrollment
128th of 193
125 · median 250
Started
2026
with 14 others
No phase
117 of 317
32 open now
Primary completion
2028-02
later than 59 of 86 live
Registered
313th of 317
by date

Among the 317 studies in Atrial Fibrillation with a site in France, this one is the 128th largest by planned enrollment of the 193 interventional ones, is one of 15 that started in 2026, is one of 117 with no phase, reaches primary completion later than 59 of the 86 other live ones, and was the 313th registered.

By phase

317 studies; the count open now beside each. This study's row is marked.

Observational124 · 25 open
No phasethis study117 · 32 open
Phase 340 · 2 open
Phase 424 · 3 open
Phase 210 · 1 open
Phase 2/32 · 0 open

By the year they started

First in 1999; this study’s year is marked. 15 started in 2026.

Size and results

Median enrollment 250 across the 193 interventional studies, 250 across the 123 observational. Of the 205 that completed or were terminated, 61 (30%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 317 studies in Atrial Fibrillation with a site in France, or all of them as a file.
02

Study 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 (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.

03

Conditions studied

  • Atrial Fibrillation

Browse trials for

Keywords

  • Volta AF-Xplorer II
  • Artificial Intelligence
  • Cardiac ablation
  • Medical Device
  • Software
  • Volta Medical
  • Spatiotemporal Dispersion
  • extra-PV substrate
  • PVI non-responder
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. to AF/AT catheter ablation.
  2. Major bleeding disorder.
  3. Contraindication to anticoagulation (Heparin, Warfarin or NOAC…) or lack of anticoagulation for 4 weeks prior to the procedure.
  4. Presence of a LA thrombus on transesophageal echocardiography (TEE) prior to the procedure.
  5. History of blood clotting or bleeding abnormalities
  6. Acute illness or active systemic infection or sepsis
  7. Any cardiac surgery within the past 2 months (60 days) (includes PCI)
  8. Myocardial infarction within the past 2 months (60 days)
  9. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
  10. Diagnosed atrial myxoma
  11. Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter
  12. Documented thromboembolic event (including ) within the past 12 months (365 days)
  13. Unstable angina within the past month
  14. Significant severe pulmonary disease, (e.g. patients with restrictive pulmonary disease, constrictive or 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)
  15. Patient who is or could potentially be pregnant.
  16. Person deprived of liberty or under guardianship.
  17. Patient's refusal to participate in the study.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
125 participants (estimated)

Study arms

  • Experimental
    Intervention: Complete biatrial mapping before and after PVI using Volta AF-Xplorer II

    Device: Complete biatrial mapping

Interventions

  • DeviceComplete biatrial mapping

    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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 12 months

Secondary outcomes

  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.

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

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

    Time frame: 12 months

07

Study locations

1 of 5 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Feb 2028, 17 months after the start.

Of 255 industry-sponsored interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's planned 17 months is below that.

Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2026
First posted
Sep 8, 2026
StartActual
Sep 22, 2026
Primary completionEst.
Feb 2028
CompletionEst.
Feb 2028
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Sep 25, 2026
Sites
5 sites changed recruiting status (4 now not yet recruiting, 1 now recruiting)
Show 5 sites
  • Clinique Rhône Durance · Avignon, Franceno status→Not yet recruiting
  • Hôpital Cardiologique Louis Pradel - HCL · Bron, Franceno status→Not yet recruiting
  • CHU Dijon · Dijon, Franceno status→Not yet recruiting
  • Hôpital Saint-Joseph Marseille · Marseille, Franceno status→Recruiting
  • Clinique Rhéna · Strasbourg, Franceno status→Not yet recruiting
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Not yet recruiting→Recruiting
    5 sites changed recruiting status (4 now not yet recruiting, 1 now recruiting)
    Show 5 sites
    • Clinique Rhône Durance · Avignon, Franceno status→Not yet recruiting
    • Hôpital Cardiologique Louis Pradel - HCL · Bron, Franceno status→Not yet recruiting
    • CHU Dijon · Dijon, Franceno status→Not yet recruiting
    • Hôpital Saint-Joseph Marseille · Marseille, Franceno status→Recruiting
    • Clinique Rhéna · Strasbourg, Franceno status→Not yet recruiting
    + 1 other change: date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07807423
Lead sponsor
Volta Medical
Responsible party
Sponsor
First posted
Sep 8, 2026
Start date
Sep 22, 2026
Primary completion
Feb 2028 (estimated)
Completion
Feb 2028 (estimated)
Last update
Sep 25, 2026

Study contacts

Paola MILPIED
Contact
paola.milpied@volta-medical.com
+33768025499
Cécile BIELMANN
Contact
cecile.bielmann@volta-medical.com
Clément BARS, MD
principal investigator · Hôpital Saint Joseph Marseille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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