Clinical Trials Directory

Trials / Recruiting

RecruitingNCT04240366

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
350 (estimated)
Sponsor
University of Luebeck · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREControl interventionpatients treated with balloon-based ablation of AF by PVI
PROCEDUREExperimental interventionpatients treated with balloon-based ablation of AF by PVI

Timeline

Start date
2019-12-17
Primary completion
2028-06-01
Completion
2028-08-01
First posted
2020-01-27
Last updated
2024-08-29

Locations

3 sites across 1 country: Germany

Source: ClinicalTrials.gov record NCT04240366. Inclusion in this directory is not an endorsement.