Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, AF, Artificial intelligence, Catheter Ablation, Ablation
Brief summary
Multi-center, international, non-randomized clinical trial evaluating the use of Volta's VX1 algorithm as used in combination with repeat catheter ablation after AF recurrence after previous catheter ablation.
Interventions
DEVICECatheter Ablation
Cardiac catheter ablation for recurrent AF after previous ablation (catheter or surgical).
Sponsors
Volta Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients 21 years of age or older indicated for redo AF ablation 2. Previous catheter or surgical ablation for paroxysmal AF, persistent AF, or long-standing persistent AF 3. Documented symptomatic AF recurrences that occurred within the last 12 months and persisted beyond 3 months after the last AF ablation procedure 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
Exclusion criteria
1. Previous ablation procedure-related complication (e.g. fistula, perforation, etc.) 2. First AF ablation procedure indication was persistent AF lasting longer than 24 months 3. Long-standing persistent AF recurrence prior to study redo procedure 4. Previous AF ablation using VX1 software 5. Severe obesity (BMI \> 50) 6. Very dilated Left Atrium (LA) (e.g. LA diameter \> 55 mm and/or LA surface \> 40 cm2 determined by 2D echocardiography) 7. Patients with AF secondary to an obvious reversible cause 8. Inadequate anticoagulation as defined in the inclusion criteria 9. LA thrombus on Transesophageal Echocardiography (TEE)\* or CT Scan prior to procedure 10. Contraindications to anticoagulation (heparin, warfarin or NOAC) 11. Patients who are or may potentially be pregnant 12. Any cardiac surgery except catheter ablation 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. Patient diagnosed with hypertrophic cardiomyopathy 16. History of blood clotting or bleeding abnormalities 17. Documented arterial thromboembolic event (including TIA) within the past 12 months (365 days) 18. Rheumatic Heart Disease 19. Cardiac Sarcoidosis 20. Chronic severe Heart Failure (NYHA functional class IV and/or LVEF \< 25%) 21. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days) 22. Unstable angina within the past month 23. Acute illness or active systemic infection or sepsis 24. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause 25. Diagnosed atrial myxoma 26. 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) 27. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment 28. Enrollment in an investigational study evaluating another device, biologic, or drug 29. Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter 30. Life expectancy or other disease processes likely to limit survival to less than 12 months 31. Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from AF | 1 year | Percent of patient free from recurrent AF episodes of \>30 seconds at 1 year after 1 study redo procedure |
Countries
Belgium, France, Germany, United States
Outcome results
None listed