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Not Yet Recruiting NCT07807423

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

Conditions: Atrial Fibrillation

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 125
Sponsor: Volta Medical

Location: Clinique Rhône Durance Avignon

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.

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07807423). StuddyBuddy aggregates publicly available trial information.