NCT04590898

Peri-device Leakage Closure After LAAO

Safety and Feasibility of Peri-device Leakage Closure After Left Atrial Appendage Occlusion

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 85 (actual)
• Sponsor: Cardiovascular Center Frankfurt · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The investigators thought to evaluate the safety and feasibility of peri-device leakage closure after left atrial appendage occlusion (LAAO, either surgical or interventional) with different devices.

Detailed description

The global burden of atrial fibrillation (AF) is high and thromboembolic stroke may be one of the fatal complications. Oral anticoagulation has been the mainstay therapy for decades to mitigate stroke risk. However, in poor candidates for long-term anticoagulation non-pharmacological stroke prevention with percutaneous left atrial appendage occlusion (LAAO) is a considerable treatment option. LAA shape and size varies widely and incomplete LAA closure or new leaks, due to LAA remodeling after the procedure, are observed in up to 30% of patients. Those leaks may cause turbulent flow and increase the risk for thrombus formation and subsequent thromboembolic events. However, the clinical significance after percutaneous LAAO has yet to be determined. If significant leaks are present, patients usually remain on oral anticoagulation. In very few cases, an interventional approach is used to close peri-device leaks. This is the first systematic study, trying to include a respectable number of patients who underwent peri-device leakage closure after LAAO. In this multi-center, collaborative study the investigators aim to identify different peri-device leak closure strategies with associated clinical outcomes and evaluate safety and feasibility of the procedure.

Conditions

• Atrial Fibrillation
• Stroke
• Bleeding
• Leakage of Cardiac Device

Interventions

Type	Name	Description
DEVICE	Peri-device leakage closure after left atrial appendage occlusion	Peri-device leakage closure after left atrial appendage occlusion

Timeline

• Start date: 2020-09-27
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2020-10-19
• Last updated: 2022-07-22

Locations

16 sites across 7 countries: United States, Denmark, Germany, Poland, Spain, Switzerland, United Kingdom