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

NCT07807423 | Recruiting

• 1 other identifier: CLIPL-05-003
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Atrial Fibrillation

Keywords

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

Outcome Measures

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.

  12 months

Secondary Outcomes (5)

• 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.

  12 months

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

  12 months

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

  12 months

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

  12 months

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

  12 months

Study Arms (1)

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

EXPERIMENTAL

Device: Complete biatrial mapping

Interventions

Complete biatrial mapping DEVICE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Volta Medical: lead

Study Sites (5)

Clinique Rhône Durance

Avignon, 84000, France

NOT YET RECRUITING

Hôpital Cardiologique Louis Pradel - HCL

Bron, 69677, France

NOT YET RECRUITING

CHU Dijon

Dijon, 21079, France

NOT YET RECRUITING

Hôpital Saint-Joseph Marseille

Marseille, 13008, France

RECRUITING

Clinique Rhéna

Strasbourg, 67000, France

NOT YET RECRUITING

Related Publications (4)

• 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: 39953289 BACKGROUND

• 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.

  PMID: 41638617 BACKGROUND

• 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: 41311304 BACKGROUND

• 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.

  PMID: 41242590 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clément BARS, MD

  Hôpital Saint Joseph Marseille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola MILPIED

CONTACT

+33768025499; paola.milpied@volta-medical.com

Cécile BIELMANN

CONTACT

cecile.bielmann@volta-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start: September 22, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)