atrial fibrillation
Conditions
Interventions
Patients will be randomized to one of the following AF ablation therapies:
- A standard AF ablation procedure consisting of isolating pulmonary vein 
(standard-of-care),
- A customized AF ablation procedure consisting of analysing and targeting 
complex physiological signals using the VX1 software, in addition to pulmonary 
vein isolation
Sponsors
Volta Medical
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Patients 18 years of age or older candidates for a first AF ablation 2. Symptomatic AF, refractory to at least one antiarrhythmic medication 3. Persistent or long-standing persistent AF with documentation of (ECG, Holter, physician*s letter): • AF duration of >= 3 months and <= 5 years or • 1 effective cardioversion followed by AF recurrence lasting >= 3 months 4. Continuous anticoagulation with warfarin (INR 2-3) or NOAC for > 4 weeks prior to ablation 5. Patients must be able and willing to provide written informed consent to participate in the clinical trial 6. Maximum of 70% of patients (240 patients) in persistent AF < 12 months (>30% of long-standing persistent AF >= 12 months)
Exclusion criteria
Exclusion criteria: 1. Paroxysmal and short-standing AF < 3 months 2. Long-standing persistent AF > 5 years 3. >= 2 previous ineffective cardioversion sessions in case of undetermined AF duration 4. Severe obesity (BMI > 40) 5. Very dilated Left Atrium (LA)(e.g. LA diameter > 55 mm and/or LA volume > 85 mL and/or LA surface > 40 cm2) 6. Patients with AF secondary to an obvious reversible cause 7. Inadequate anticoagulation as defined in the inclusion criteria 8. LA thrombus on Transesophageal Echocardiography (TEE) prior to procedure 9. Contraindications to anticoagulation (heparin, warfarin or NOAC) 10. Patients who are or may potentially be pregnant 11. Previous surgical or catheter ablation for AF 12. Any cardiac surgery within the past 2 months (60 days) (includes PCI) 13. Myocardial infarction within the past 2 months (60 days) 14. Previous AV valve surgery 15. History of blood clotting or bleeding abnormalities 16. Documented thromboembolic event (including TIA) within the past 12 months (365 days) 17. Rheumatic Heart Disease 18. Chronic severe Heart Failure (NYHA functional class III and IV and/or LVEF < 25%) 19. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days) 20. Unstable angina within the past month 21. Acute illness or active systemic infection or sepsis 22. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause 23. Diagnosed atrial myxoma 24. Significant severe pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms 25. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment 26. Enrollment in an investigational study evaluating another device, biologic, or drug 27. Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter 28. Life expectancy or other disease processes likely to limit survival to less than 12 months 29. Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Freedom from documented AF*, with or without AADs, 12 months after a single index ablation procedure. *Freedom from documented AF is defined as no documented episodes of AF > 30 seconds with conventional non-invasive monitoring (Holters, TTM and 12-lead ECG recordings) between 3 and 12 months after index procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Freedom from documented AF/AT*, after one procedure, with or without AADs, at 12 months 3. Freedom from documented AF/AT*, after one procedure or more, with or without AADs, at 12 months 4. Freedom from documented AF*, after one procedure or more, with or without AADs, at 12 months 5. Safety composite endpoint at 12 months: death, cerebrovascular events, or serious treatment-related adverse event *Freedom from documented AF or AF/AT is defined as no documented episodes of AF/AT > 30 seconds with conventional non-invasive monitoring (Holters, TTM and 12-lead ECG recordings) between 3 and 12 months after index procedure | — |
Countries
Netherlands
Outcome results
None listed