Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation (LALA-LAND-AF)

University of Luebeck

Status: Enrolling

Conditions: Persistent or Long-standing Persistent Atrial Fibrillation

Treatments: Procedure: Experimental intervention; Procedure: Control intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04240366

19-323

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Group 1

Other group

Description:

Balloon-based ablation of atrial fibrillation by pulmonary vein isolation alone

Treatment:

Procedure: Control intervention

Group 2

Experimental group

Description:

Balloon-based ablation of atrial fibrillation by pulmonary vein and left atrial appendage isolation

Treatment:

Procedure: Experimental intervention