Persistent Atrial Fibrillation
Conditions
Brief summary
The purpose of this trial is to assess acute safety and performance of the Multi-electrode Linear Type Catheter in conjunction with generator software V2.4.0 or above when used for the treatment of Persistent Atrial Fibrillation.
Interventions
DEVICEEndocardial Ablation Procedure
Sponsors
Biosense Webster, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 18 years. 2. Signed the Patient Informed Consent Form (ICF) 3. Documented ongoing or previous symptomatic persistent AF (by physician's note indicating continuous AF ≥ 7 days) 4. Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD. 5. Able and willing to comply with all pre-, post-, and follow-up testing and requirements.
Exclusion criteria
1. Previous surgical or catheter ablation for atrial fibrillation 2. Current condition of continuous AF \> 12 months (1 year) (Longstanding Persistent AF) or previously diagnosed as having Longstanding Persistent AF 3. Any carotid stenting or endarterectomy 4. Known with Cardioversion refractory history (the inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion. 5. LA size \> 55 mm 6. LVEF \<40% 7. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause 8. Significant pulmonary disease (i.e. 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 9. Uncontrolled heart failure or NYHA function class III and IV 10. MI within the past 2 months 11. Any cardiac surgery (i.e. CABG) within the past 2 months 12. Subjects that have ever undergone valvular cardiac surgical/ percutaneous procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve) 13. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months 14. Documented thromboembolic event (including TIA) within the past 12 months 15. Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study 16. Active illness or active systemic infection or sepsis 17. Unstable angina 18. History of blood clotting or bleeding abnormalities 19. Contraindication to anticoagulation (eg, heparin or warfarin) 20. Life expectancy less than 12 months 21. Presence of intracardiac thrombus, myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation 22. Presence of a condition that precludes vascular access 23. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation 24. Currently enrolled in another device, biologics, or drug study 25. Contraindication for use of the investigational devices , as indicated in the respective Instructions For Use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early Onset of Primary Adverse Events | Within 7 days | Incidence of early onset (within 7 days of ablation procedure) primary Adverse Events |
| Confirmation of entrance block | Intraoperative | Acute procedural success defined as: Confirmation of entrance block in all targeted PVs after adenosine and /or isoproterenol challenge (taking into account a 30 minute waiting period from the last RF application at a PV target before verification) |
| Confirmation of bi-directional block | Intraoperative | Acute procedural success defined as: Confirmation of bi-directional block in all linear lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Serious Adverse Device Effects (SADEs) | 1 Year | Incidence of Serious Adverse Device Effects (SADEs) during follow-up |
| Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia | 3, 6 and 12 months post-procedure | Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia recurrence at 3, 6 and 12 months post-procedure |
Outcome results
None listed