Peri-device Leakage Closure After LAAO
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| significant peri-device leakage after LAA occlusion Peri-device leakage closure after left atrial appendage occlusion |
Device: Peri-device leakage closure after left atrial appendage occlusion
Peri-device leakage closure after left atrial appendage occlusion
|
Outcome Measures
Primary Outcome Measures
- Procedural mortality [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 clinically relevant pericardial effusion [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
- Procedure-related ischemic stroke [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 Outcome Measures
- Bleeding complications [through study completion, an average of 1 year]
Number of participants experiencing bleeding complications evaluated by using VARC-2 criteria with LAAO specific modifications (after the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies)
- Vascular access site complications [during procedure, assessed up to 7 days]
Number of participants experiencing retroperitoneal haematoma, AV-fistula, arterial complications, venous complications, symptomatic peripheral ischemia, nerve injury with clinical symptoms >24h, vascular surgical repair at access site, pulmonary embolism, ipsilateral deep vein thrombosis, access site-related infection requiring iv. antibiotics or extended hospitalization
- Liver- and kidney failure associated with the procedure [In-hospital stay, assessed up to 30days]
Number of participants experiencing liver- and kidney failure potentially associated with the procedure evaluated by using the definitions of Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies
- Device-associated complications [through study completion, an average of 1 year]
Number of participants experiencingdevice migration, perforation, laceration, erosion, device infection, pericarditis, device-related thrombus and persistent or occurrence of new peri-device leakage
- Ischemic stroke or transitory ischemic attack [through study completion, an average of 1 year]
Number of participants experiencing an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction of central nervous system tissue not directly related to the procedure
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients after interventional or surgical left atrial appendage occlusion with severe leakage, who underwent interventional peri-device leakage closure
Exclusion Criteria:
- n/a
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | • Banner University Medical Center Phoenix | Phoenix | Arizona | United States | 85006 |
| 2 | Scripps Health | La Jolla | California | United States | 92037 |
| 3 | Kansas City Heart Rhythm Institute | Overland Park | Kansas | United States | 66211 |
| 4 | Mayo Clinic Hospital - Saint Mary's Campus | Rochester | Minnesota | United States | 55902 |
| 5 | Vanderbilt Heart Institute | Nashville | Tennessee | United States | 37212 |
| 6 | Austin Heart | Austin | Texas | United States | 78756 |
| 7 | University of Utah Hospital | Salt Lake City | Utah | United States | 84132 |
| 8 | Aarhus University Hospital | Aarhus | Denmark | 8200 | |
| 9 | Rigshospitalet Copenhagen | Copenhagen | Denmark | 2100 | |
| 10 | Cardio Vascular Center Frankfurt | Frankfurt | Hesse | Germany | 60389 |
| 11 | Universitätsklinikum Düsseldorf | Düsseldorf | North Rhine-Westphalia | Germany | 40225 |
| 12 | Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF) | Berlin | Germany | 12200 | |
| 13 | Poznan University of Medical Sciences | Poznan | Poland | 61701 | |
| 14 | Hospital Universitario de Salamanca | Salamanca | Spain | 37007 | |
| 15 | Inselspital Bern | Bern | Switzerland | 3010 | |
| 16 | Nuffield Health | Headington | United Kingdom | OX3 7RP |
Sponsors and Collaborators
- Cardiovascular Center Frankfurt
Investigators
- Study Chair: Kerstin Piayda, University Hospital Düsseldorf and Cardio Vascular Center Frankfurt
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CVC-002