atrial fibrillation Irregular heartbeat
Conditions
Interventions
Patients will undergo the standard catheter ablation procedure in accordance
with good clinical practice, performing PVI with the pentaspline PFA system. In
the control group PVI will be performed w
Sponsors
Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients with paroxysmal atrial fibrillation or persistent atrial fibrillation who have undergone no more than 1 cardioversion and are usually in SR, between 18 and 80 years of age, who will be treated with the pentaspline PFA ablation system, have no contraindication to ablation and its associated procedures, and are able to understand and complete the study for a follow-up duration of >12 months
Exclusion criteria
Exclusion criteria: Patients with chronic atrial fibrillation, younger than 18 years of age, with moderate-severe valvular disease, a severely dilated left atrium, heart failure, COPD GOLD 3 or more, moderate to severe OSAS, serious cardiac disease for which a cardiac intervention in the last or next 3 months, anatomical features that make ablation impossible, CVA in the last 6 months, kidney disease with GFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the primary study parameter for efficacy is the freedom of atrial arrhythmias after the 2-month blanking period up to 12 months after the procedure. The primary safety outcome is the major adverse event rate of the higher dosing versus the standard dosing arm. The primary safety outcome is the major adverse event rate of the higher dosing versus the standard dosing arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| Extent and position of pulmonary vein reconnection during redo procedures required because of recurrence of arrhythmias that constitute an endpoint in the study. Arrhythmia burden post-procedure in centers that also use photo-phlethysmografic remote-monitoring as standard of care for all their ablation patients. | — |
Countries
Netherlands
Contacts
Public ContactI.N. Bax
Antonius Ziekenhuis
Outcome results
None listed