AF Atrial fibrillation
Conditions
Interventions
CFAE guided ablation
PVI guided ablation
Sponsors
Maatschap Cardiologie Zwolle
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with persistent atrial fibrillation, defined as atrial fibrillation which is: a. Sustained beyond 7 days but no more than one year b. Or lasting less than 7 days, but longer than 48 hours and necessitating pharmacologic or electrical cardioversion 2. Documentation of atrial fibrillation on either a 12-lead ECG or transtelephonic monitoring (TTM), or ambulatory holter monitoring or telemetry strip and a physician*s note showing continuous AF. 3. Failure of at least one antiarrhythmic drug (AAD) (Class I or III) as evidenced by recurrent symptomatic AF or intolerable side effects of the AAD.
Exclusion criteria
Exclusion criteria: 1. Continuous AF > 12 months (1-Year) (Longstanding Persistent AF) 1. Previous surgical or catheter ablation for atrial fibrillation 2. Any cardiac surgery within the past 2 months (60 days) (includes PCI) 3. CABG surgery within the past 6 months (180 days) 4. Subjects that have ever undergone valvular cardiac surgical procedure 5. Cardioversion refractory (the inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion). 6. Documented LA thrombus on imaging 7. LA size >50 mm 8. LVEF
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from recorded atrial fibrillation or atrial flutter or atrial tachycardia recurrences (>30 seconds) without the use of AADs through 18 months follow-up, post-blanking, on either a 12 lead ECG on visits or on 24 hour holter monitoring or on symptom-driven event monitoring. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Freedom from recorded atrial fibrillation or atrial flutter or atrial tachycardia recurrences (>30 seconds) through 18 months follow-up on either a 12 lead ECG on visits or on 24 hour holter monitoring or on symptom-driven event monitoring, regardless of antiarrhythmic drugs • Freedom from recorded atrial fibrillation or atrial flutter recurrences (>30 seconds) through 18 months follow-up on either a 12 lead ECG on visits or on 24 hour holter monitoring or on symptom-driven event monitoring, regardless of antiarrhythmic drugs • Freedom from recorded atrial fibrillation or atrial flutter or atrial tachycardia recurrences (>30 seconds) through 18 months follow-up on either a 12 lead ECG on visits or on 24 hour holter monitoring or on symptom-driven event monitoring, without a new AAD or a previously failed AAD at a greater than the highest ineffective historical dose • Freedom from recorded atrial fibrillation (>30 seconds) through 18 months follow-up on either a 12 lead ECG on visits or on 24 hour holter monitoring or on symptom-driven event monitoring, regardless of antiarrhythmic drugs • Clinical/partial success at 18 months regardless of antiarrhythmic drug use, defined as a 75% or greater reduction in the number of AF episodes and/or the duration of AF episodes, or the % time a patient is in AF as assessed with a device capable of measuring AF burden. • Time to first symptomatic, recorded AF recurrence • Time to first electrocardioversion • Symptoms associated with atrial arrhythmias • Decreased anti-arrhythmic and/or anticoagulant drug requirements • Quality of life at 6 and 12 months compared to baseline • Number of redo-procedures • Total time of fluoroscopy • Total procedure time (minutes from introduction of first catheter to withdrawal of last catheter) • Total ablation time | — |
Countries
France, Japan, Netherlands
Contacts
Public ContactJ.J.J. Smit
Maatschap Cardiologie Isala
Outcome results
None listed