I48
Conditions
Interventions
Group 1: Pulmonary vein isolation using focal pulsed field ablation. The patients in this group are undergoing the ablation of pulmonary veins using focal pulsed field ablation. The follow-up is 1 yea
Sponsors
Universitätsklinikum Düsseldorf
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Paroxysmal or persistent atrial fibrillation
Exclusion criteria
Exclusion criteria: Contraindications for oral anticoagulation Contraindications for the pulmonary vein isolation Left atrial diameter >6 cm Left atrial redo procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom of atrial tachyarrhythmias during the first year after ablation. Per definition we search for sustained atrial arrhythmias over 30 seconds. The endpoint is assessed based on symptoms and using Holter ECGs. The Holter ECGs are planed at 3, 6 and 12 months after the procedure, as well as symptom-triggered. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of symptoms. We aim to document the change in AFEQT (AF Effect On Quality-Of-Life Questionnaire) questionnaire before and after the ablation (3,6 and 12 months). Safety - the intra- and postprocedural occurrence of major complications, defined as: pericardial tamponade, stroke, major groin complication, phrenic nerve injury, atrio-esophageal fistula. | — |
Countries
Germany
Contacts
Public ContactObaida Rana
Universitätsklinikum Düsseldorf
Outcome results
None listed