Control intervention
Procedurepatients treated with balloon-based ablation of AF by PVI
Other names: Balloon-based ablation of atrial fibrillation by pulmonary vein isolation alone
NCT Number: NCT04240366
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.
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Request Info18 year and older
All sexes
Interventional
Not applicable
Asklepios Klinik Altona, Hamburg, Free and Hanseatic City of Hamburg, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
patients treated with balloon-based ablation of AF by PVI
Other names: Balloon-based ablation of atrial fibrillation by pulmonary vein isolation alone
patients treated with balloon-based ablation of AF by PVI
Other names: Experimental: Group 2 Balloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolation
Time frame: 3 - 12 months
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
Contact information is provided by the study sponsor or research team.
University of Luebeck
Other
Acronym: LALA-LAND-AF
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