Additional left atrial appendage isolation during balloon ablation for persistent or long-standing persistent atrial fibrillation can reduce atrial fibrillation reoccurrence within 3-12 months compared to balloon-based pulmonary vein isolation only.
The intervention in the LALA-LAND-AF trial is the additional LAAI in patients with catheter ablation for persistent AF and will be performed once as index ablation as outlined above. With exception of the index ablation, all patients will be treated according to the current clinical practice guidelines for AF as stated by the European Society of Cardiology (ESC) 11,18 and an expert consensus statement on catheter and surgical ablation1. Patients may be treated with a specific antiarrhythmic drug (AAD) for a maximum of 3 months following the index ablation. No repeat ablation for AF should be performed within the first 3 months. Thereafter, repeat ablations are permitted for recurrent AF irrespective of group allocation. Ablation strategy at repeat ablation includes PV re-isolation if required in both groups and re-isolation of the LAA in the intervention group. In the control group, LAAI may only be performed in case all PV were isolated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
patients treated with balloon-based ablation of AF by PVI
patients treated with balloon-based ablation of AF by PVI
University Hospital Eppendorf, Hamburg, Germany
Hamburg, Hamburg, Germany
RECRUITINGAsklepios Klinik Altona
Hamburg, Hamburg, Germany
RECRUITINGClinic for Rhythmologiy Luebeck, Schleswig-Holstein Germany
Lübeck, Schleswig-Holstein, Germany
RECRUITINGTime until any documented episode of ATa
Time until any documented episode of atrial tachyarrhythmia (ATa: atrial fibrillation or atrial tachycardia) lasting longer than 30 seconds within 3-12 months after index ablation without antiarrhythmic therapy
Time frame: 3 - 12 months
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