Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Control intervention, Experimental intervention.
- Who it may be relevant to
- Registry conditions: Persistent or Long-standing Persistent Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Procedure Control intervention
patients treated with balloon-based ablation of AF by PVI - Procedure Experimental intervention
patients treated with balloon-based ablation of AF by PVI
Primary outcome measures
- Time until any documented episode of ATa [Time frame: 3 - 12 months]
Eligibility criteria
Inclusion criteria
- Persistent or long-standing persistent AF (i.e. continuous AF that was/is sustained >7 days or >12 months, respectively)
- Age ≥18 and ≤80 years
- Indication for AF ablation as per current guidelines
Exclusion criteria
- Missing informed consent
- LAA diameter >25mm 10mm distant from circumflex artery assessed by TEE
- Paroxysmal atrial fibrillation
- Long-standing persistent atrial fibrillation with a continuous AF duration of >4 years
- Previous pulmonary vein isolation or MAZE surgery
- Previous led atrial appendage closure or surgical excision
- Left atrial diameter >60 mm at baseline
- Left atrial thrombus at baseline
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 3 centers
- University Hospital Eppendorf, Hamburg, Germany — Hamburg
- Asklepios Klinik Altona — Hamburg
- Clinic for Rhythmologiy Luebeck, Schleswig-Holstein Germany — Lübeck
Identifiers
NCT: NCT04240366 · 19-323