Atrial fibrillation
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Patients age is * 18 years and * 80 years - Patients must provide written, informed consent - Patients with paroxysmal or persistent drug-refractory, symptomatic atrial fibrillation. Persistent AF is defined as sustained episodes of atrial fibrillation lasting >7 days. - Patients undergoing a first time ablation procedure for atrial fibrillation - All pulmonary vein diameters at computed tomography or magnetic resonance imaging * 23 mm - AF must be recorded at least once by ECG, holter, telemetry, loop recorder or internal device - Patients have non-valvular AF
Exclusion criteria
Exclusion criteria: - Not capable of giving informed consent - Prior PVAI with RF or Cryo ablation - Patients with longstanding persistent AF (defined as sustained episode lasting >1 year) - One or more PVs with a diameter at computed tomography or magnetic resonance imaging > 23 mm - Patients with any exclusion criteria or contra-indications for electrophysiologic study and ablation in the LA, such as pregnancy or presence of a LA thrombus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess: - Acute pulmonary vein isolation with entrance and exit block - Acute device related complications | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess: - Maneuverability of IRE catheter in the left atrium - Positioning of catheter at PV antrum - Acute procedural complications - Procedural duration - Fluoroscopy time - Feasibility of MEIS contact measurements | — |
Countries
Netherlands