Safety and Feasibility of Peri-device Leakage Closure After Left Atrial Appendage Occlusion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 85
- Locations
- 16
- Primary Endpoint
- Procedure-related clinically relevant pericardial effusion
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients after interventional or surgical left atrial appendage occlusion with severe leakage, who underwent interventional peri-device leakage closure
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Procedure-related clinically relevant pericardial effusion
Time Frame: In-hospital stay, assessed up to 30days
Number of participants experiencing pericardial effusion with hemodynamic relevance, treated with therapeutic pericardiocentesis or surgical intervention, requiring blood transfusion or resulting in shock and/or death, which was procedure related
Procedural mortality
Time Frame: In-hospital stay, assessed up to 30days
Rate of all-cause mortality during the index procedure, number of participants experiencing a procedure-related death within 30days or during in-hospital stay for the index procedure (if\>30days)
Procedure-related ischemic stroke
Time Frame: In-hospital stay, assessed up to 30days
Number of participants experiencing an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue, which was procedure related
Secondary Outcomes
- Vascular access site complications(during procedure, assessed up to 7 days)
- Liver- and kidney failure associated with the procedure(In-hospital stay, assessed up to 30days)
- Device-associated complications(through study completion, an average of 1 year)
- Bleeding complications(through study completion, an average of 1 year)
- Ischemic stroke or transitory ischemic attack(through study completion, an average of 1 year)