Atrial fibrillation
Conditions
Interventions
None listed
Sponsors
Academisch ziekenhuis Maastricht (azM)
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this registry, a subject must meet all of the following criteria: · 18 years of age or older; · Documented atrial fibrillation; · Scheduled for AF ablation or redo AF ablation; · Able and willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this registry: · Serious patient condition before ablation; · Physically or mentally unable to provide written informed consent. A subject who meets any of the following criteria will be excluded from the subset in whom additional consent for transesophageal ECG (TE-ECG) is asked: · Known esophageal disease; · Previous surgery on esophagus, throat or stomach; · Recent (<4 weeks) myocardial infarction; · Unwilling to provide additional informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is ablation success, defined as freedom from documented recurrence of atrial arrhythmia after 12 months. Recurrences in the first 3 months after the index procedure (blanking period) are exempted. Atrial arrhythmias are atrial fibrillation (AF), atrial tachycardia (AT) and non-isthmus dependent atrial flutter (AFl), lasting more than 30 seconds, documented on electrocardiogram (ECG) or Holter monitoring. | — |
Secondary
| Measure | Time frame |
|---|---|
| · Time to recurrence of atrial arrhythmia after the blanking period. · Time to recurrence of AF after the blanking period. · Early AF recurrences, defined as any episode of AF during the blanking period. · Early recurrences of atrial arrhythmia, defined as any episode of AF, AT or non-isthmus dependent AFl during the blanking period. · Changes in circulating biomarkers and non-invasive electrophysiological markers for substrate quantification. · Use of antiarrhythmic drugs (AADs) one year after ablation. · Redo procedures, defined as repeated ablation procedure with the goal to prevent recurrence of AF or reduce the AF burden after one or more previous attempts to achieve the same goal. · Number of veins with pulmonary vein reconnection at redo procedure. · Major adverse cardiovascular events (MACE). | — |
Contacts
Public ContactDominique Verhaert
Maastricht UMC+
Outcome results
None listed