RecruitingNot ApplicableNCT04240366
Additional Left Atrial Appendage Isolation During Balloon Ablation for Persistent or Long-standing Persistent Atrial Fibrillation
Sponsor
University of Luebeck
Enrollment
350 participants
Start Date
Dec 17, 2019
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria8
- 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
Interventions
PROCEDUREControl intervention
patients treated with balloon-based ablation of AF by PVI
PROCEDUREExperimental intervention
patients treated with balloon-based ablation of AF by PVI
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT04240366