Persistent atrial fibrillation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with initial ablation for persistent atrial fibrillation (lasting for >7 days and <3 years) At least 1 episode of persistent AF have been documented within last 1 y of enrollment
Exclusion criteria
Exclusion criteria: Patients who underwent prior cardiac surgery Patients with left atrial size >55 mm Patients with heart failure (NYHA class 4) Patients with AF secondary to a reversible cause Patients with contraindications to systemic anticoagulation Patients who are pregnant Patients receiving hemodialysis Patients who are not considered to be suitable candidates by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from any documented atrial arrhythmias during 18 months follow-up after a single ablation procedure with or without the use of antiarrhythmic medications | — |
Secondary
| Measure | Time frame |
|---|---|
| Freedom from any documented atrial fibrillation (AF) episodes Freedom from any documented atrial tachycardia/flutter episodes AF burden between study arms Freedom from any documented symptomatic atrial arrhythmias Procedural duration and fluoroscopy time Posterior wall isolation success rate Freedom from repeat ablation procedure Freedom from direct current cardioversions for recurrent arrhythmias Peri-procedural complications Assessment of upper gastrointestinal symptom severity index during peri-procedural period The impact of the use of cryoballoon Wristwatch-Based Photoplethysmography for arrhythmia detection The impact of area of isolated posterior wall on outcomes The impact of the presence of left atrial low voltage area on outcomes Type of ablation catheters and 3-dimensional mapping systems Pulmonary vein isolation durability during second procedure Freedom from any documented atrial arrhythmias after repeat ablation procedure with or without the use of antiarrhythmic medications | — |
Countries
Japan
Contacts
Tokyo Medical and Dental University Department of cardiovascular medicine