Atrial fibrillation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age = 18 yearsPersistent atrial fibrillation (as defined as a sustained episode lasting >7 days and <1 year) or longlasting atrial fibrillation (defined as a sustained episode lasting >1 year and <3 years).Scheduled to undergo a catheter ablation for atrial fibrillationLegally competent and willing to provide informed consent.
Exclusion criteria
Exclusion criteria: Age < 18 years.Pregnancy.Patients with a sustained episode of atrial fibrillation lasting >3 years.Paroxysmal atrial fibrillationA prior ablation (catheter ablation or minimally-invasive thoracoscopic ablation) for atrial fibrillation or any other cardiac arrhythmia.Patients with contraindications to systemic anticoagulation with heparin or Coumadin or a direct thrombin inhibitor.Patients with thromboemboli in left atrial appendage.Patients with left atrial size =55 mm or =45ml/m2 (2-dimensional echocardiography, parasternal long-axis view).Patients with severe structural cardiac disease (severe mitral regurgitation, dilated cardiomyopathy, hypertrophy cardiomyopathy, other severe valvular heart diseases).Patients with the serum creatinine >3.5 mg/dL or creatinine clearance rate <30 mL/min.Patients with life expectancy <12 months.Patient's refusal to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is feasibility of HSC ablation, defined as the proportion of patients in whom =75% of identified HSC sites demonstrate loss of capture following ablation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Freedom from AF one year after the procedure without the use of antiarrhythmic drugs. Freedom from AF is defined (by convention) as the time from the end of the 3-month blanking period to the first documented episode of AF, non cavotriscupid isthmus dependent atrial flutter or atrial tachycardia >30 seconds on all holters and ECG recordings during follow up.(2)Atrial electroanatomic map will be acquired with tags according to APPENDIX 1.Atrial electrograms during and after the application of the triple extrastimuli that are assessed for hidden slow conduction as specified in APPENDIX 2.Time to first persistent AF (more than 7 days) after blanking period (efficacy),Any atrial arrhythmia (excluding CTI flutter) on antiarrhythmic drugs at 12 months after a single ablation procedure after blanking period (efficacy)AF burden (% time AF in 24h Holter) (efficacy)Incidence of periprocedural complications (safety)Procedure time (feasibility)Fluoroscopy time (feasibility)Number of RF applications (efficiency)RF delivery time (efficiency) | — |
Countries
Netherlands
Contacts
Amsterdam UMC