Persistent or Long-standing Persistent Atrial Fibrillation
Conditions
Brief summary
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
PROCEDUREControl intervention
patients treated with balloon-based ablation of AF by PVI
PROCEDUREExperimental intervention
patients treated with balloon-based ablation of AF by PVI
Sponsors
IHF GmbH - Institut für Herzinfarktforschung
University of Luebeck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Persistent or long-standing persistent AF (i.e. continuous AF that was/is sustained \>7 days or \>12 months, respectively) 2. Age ≥18 and ≤80 years 3. Indication for AF ablation as per current guidelines
Exclusion criteria
1. Missing informed consent 2. LAA diameter \>25mm 10mm distant from circumflex artery assessed by TEE 3. Paroxysmal atrial fibrillation 4. Long-standing persistent atrial fibrillation with a continuous AF duration of \>4 years 5. Previous pulmonary vein isolation or MAZE surgery 6. Previous led atrial appendage closure or surgical excision 7. Left atrial diameter \>60 mm at baseline 8. Left atrial thrombus at baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time until any documented episode of ATa | 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 |
Countries
Germany
Contacts
Primary ContactRoland Tilz, Prof. Dr.
Backup ContactCharlotte Eitel, Prof. Dr.
Outcome results
None listed