Identifying AF patients who may need more than standard ablation using Volta AF-Xplorer II

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

DISPLAY-AF is a prospective, multicenter, single-arm study that follows patients with persistent atrial fibrillation from ablation through 12 months to see if dispersion areas highlighted by Volta AF-Xplorer II relate to later AF recurrence. All patients undergo a complete biatrial mapping during de novo PVI-only procedures, with follow-up visits at 3, 6, and 12 months including ECGs, Holter monitoring, and quality-of-life assessments. The study builds on prior work suggesting that non-pulmonary vein substrates contribute to AF maintenance and uses AI-guided dispersion analysis to characterize these patterns during ablation. The goal is to determine whether AI-identified dispersion can inform prognosis after standard ablation.

Why it matters

Who can join: the full rules

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:

1. Contraindication 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 TIA) 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 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)
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.

Where it's running

• Hôpital Saint-Joseph Marseille
  Marseille, France Recruiting
• Clinique Rhône Durance
  Avignon, France Not yet recruiting
• Hôpital Cardiologique Louis Pradel - HCL
  Bron, France Not yet recruiting
• CHU Dijon
  Dijon, France Not yet recruiting
• Clinique Rhéna
  Strasbourg, France Not yet recruiting

Study contacts

• Principal investigator: Clément BARS, MD — Hôpital Saint Joseph Marseille
• Study coordinator: Paola MILPIED
• Email: paola.milpied@volta-medical.com
• Phone: +33768025499

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.