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

N/ANot Yet RecruitingNCT07807423

Volta Medical125 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

125

Conditions

Atrial Fibrillation

Interventions

Complete biatrial mappingDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Clinique Rhône Durance

Avignon, France

Hôpital Cardiologique Louis Pradel - HCL

Bron, France

CHU Dijon

Dijon, France

Hôpital Saint-Joseph Marseille

Marseille, France

Clinique Rhéna

Outcomes

Primary Outcomes

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

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

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

Time frame: 12 months

Volta AF-Xplorer II-related Serious Incident rate.

Time frame: 12 months

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

Time frame: 12 months

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

Time frame: 12 months

Central Contacts

Paola MILPIED

CONTACT

+33768025499 paola.milpied@volta-medical.com

Cécile BIELMANN

CONTACT

cecile.bielmann@volta-medical.com

Data from ClinicalTrials.gov

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