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NCT07807423From ClinicalTrials.govRecruiting

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

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

  • Atrial Fibrillation

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Volta Medical
Enrolment target
125
Started
22 September 2026
Main results due
February 2028
Study sites
5
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(5)

  • 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

  • Hôpital Saint-Joseph Marseille

    Marseille, France

    Recruiting

  • Clinique Rhéna

    Strasbourg, France

    Not yet recruiting

Showing 5 of 5 sites. 1 of the 5 sites on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07807423. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Use of Volta Medical AI-software During Atrial Fibrillation Ablation to Identify Patients Who May Need More Th | Trialion