Drug refractory symptomatic paroxysmal atrial fibrillation Circulatory System Drug refractory symptomatic paroxysmal atrial fibrillation
Conditions
Interventions
Patient will undergo atrial fibrillation ablation procedure using the novel radiofrequency catheter. The intervention involves introduction of the study RF catheter, ablation of targeted pulmonary vei
Sponsors
Biosense Webster, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Symptomatic paroxysmal atrial fibrillation with at least one documented atrial fibrillation episode within one year prior to enrollment 2. Failed at least one antiarrhythmic drug (class I or III) 3. Pre-procedural anticoagulation on warfarin, rivaroxaban or apixaban. If receiving warfarin therapy, patients must agree to take warfarin for at least 4 weeks prior to the scheduled ablation procedure. 4. Age 18 years or older 5. Able and willing to comply with all pre-, post- and follow-up testing and requirements (e.g. Patient not confined by a court ruling) 6. Signed Patient Informed Consent Form
Exclusion criteria
Exclusion criteria: 1. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause 2. Previous surgical or catheter ablation for atrial fibrillation 3. Previously diagnosed with persistent or longstanding atrial fibrillation 4. Any percutaneous coronary intervention (PCI), cardiac surgery, or valvular cardiac surgical or percutaneous procedure (e.g. ventriculotomy, atriotomy) within the past 2 months 5. Valve repair or replacement and presence of a prosthetic valve 6. Any carotid stenting or endarterectomy 7. Coronary artery bypass grafting surgery within the past 6 months 8. Documented left atrium thrombus on baseline/pre-procedure imaging 9. LA size > 55 mm 10. Left Ventricular Ejection Fraction (LVEF) < 40% 11. Contraindication to anticoagulation (heparin or warfarin) 12. Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. 13. History of blood clotting or bleeding abnormalities 14. Myocardial infarction within the past 2 months 15. Documented thromboembolic event (including transient ischemic attack [TIA]) within the past 12 months 16. Rheumatic Heart Disease 17. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV 18. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months 19. Unstable angina 20. Acute illness or active systemic infection or sepsis 21. Diagnosed atrial myxoma 22. Presence of implanted pacemaker, implantable cardioverter defibrillator (ICD), or tissue-embedded, iron-containing metal fragments 23. Significant 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 24. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study 25. Unresolved pre-existing neurological deficit 26. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation 27. Enrollment in an investigational study evaluating another device, biologic, or drug 28. Has known pulmonary vein stenosis 29. Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter 30. Presence of a condition that precludes vascular access 31. Life expectancy or other disease processes likely to limit survival to less than 12 months 32. Presenting contra-indication for the devices (e.g. esophageal endoscope, CT, etc.) used in the study, as indicated in the respective instructions for use 33. Categorized as a vulnerable population and require special treatment with respect to safeguards of well-being (e.g. cognitively impaired, veteran, prisoner, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of primary adverse events* within 7 days of the ablation procedure is measured by an assessment by the doctor either via telephone or in-clinic who will check the patient’s overall status and whether or not any primary adverse events have occurred since the ablation procedure, 7 days post-ablation. *Primary adverse events include: Cardiac Tamponade/Perforation, Death, Diaphragmatic Paralysis, Heart Block, Myocardial Infarction, Pericarditis, Pneumothorax, Pulmonary Edema, Stroke/Cerebrovascular Accident, Thromboembolism, Transient Ischemic Attack, Vascular Access Complication, Atrio-Esophageal Fistula, and Pulmonary Vein Stenosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serious adverse events and other adverse events are assessed by the doctor at the 30-day peri-procedural clinic visit and 3 months post-procedure 2. PV stenosis rate is assessed using CT/MRA pre-ablation and 3 months 3. Incidence of pre- and post-ablation asymptomatic cerebral emboli is assessed using cerebral MRI pre-ablation and pre-discharge 4. Incidence of new or worsening neurologic deficits is assessed using a neurological assessment pre and post-ablation 5. Incidence of post-ablation esophageal lesion/injury is assessed using an endoscopy within 48 hours post-ablation | — |
Countries
Czech Republic, Italy, United Kingdom
Contacts
Public ContactStephanie Plaza
Outcome results
None listed