I48.9
Conditions
Interventions
Group 1: Group A will receive an ablation according to current clinical routine. In the intervention performed with the Affera system, it will first be verified whether the primary goal of pulmonary v
Sponsors
Deutsches Herzzentrum der Charité
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: All patients with a diagnosis of persistent atrial fibrillation who, after a primary pulmonary vein isolation, experienced a recurrence of atrial fibrillation outside the blanking period and are scheduled for a repeat procedure will be included. Only patients older than 18 years who are able to provide informed consent for both the catheter-based intervention and participation in the study will be enrolled.
Exclusion criteria
Exclusion criteria: Patients will be excluded if they developed an atypical atrial tachycardia following the initial pulmonary vein isolation, are under 18 years of age, lack the capacity to provide informed consent, or if structured follow-up is not feasible due to social or medical circumstances.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is freedom from atrial fibrillation recurrences at 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints include recurrence-free survival at 24 months, quality of life following atrial fibrillation ablation over the follow-up period, the extent of dispersion in the intraprocedural map, and procedural safety with respect to major adverse cardiovascular events (MACE, including mortality, hospitalization, and stroke, as recorded in the medical history) during follow-up. | — |
Countries
Germany
Contacts
Public ContactFelix Hohendanner
Deutsches Herzzentrum der Charité
Outcome results
None listed