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

U

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

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)

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

Trial contacts and locations

1

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Central trial contact

Charlotte Eitel, Prof. Dr.; Roland Tilz, Prof. Dr.

Data sourced from clinicaltrials.gov

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