Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation
Recruiting · NCT04240366 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Luebeck
View the official record on ClinicalTrials.gov →Interventions studied
Control interventionExperimental intervention
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
3 locations listed.
- University Hospital Eppendorf, Hamburg, Germany - Hamburg, Free and Hanseatic City of Hamburg, Germany
- Asklepios Klinik Altona - Hamburg, Free and Hanseatic City of Hamburg, Germany
- Clinic for Rhythmologiy Luebeck, Schleswig-Holstein Germany - Lübeck, Schleswig-Holstein, Germany