Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Luebeck
- Enrollment
- 350
- Primary Endpoint
- Time until any documented episode of ATa
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Time until any documented episode of ATa
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Prof. Roland Richard Tilz
Head of Electrophysiology Department
University of Luebeck