Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation

Not Applicable

Recruiting

• Conditions: Persistent or Long-standing Persistent Atrial Fibrillation

• Registration Number: NCT04240366
• Lead Sponsor: University of Luebeck

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.

Study Timeline

• Study Start: 2019-12-17
• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2020-01-23
• Study First Posted: 2020-01-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29
• Primary Completion: 2028-06
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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