Clinical trial NCT04590898: Peri-device Leakage Closure After LAAO
Official title: Safety and Feasibility of Peri-device Leakage Closure After Left Atrial Appendage Occlusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Stroke
Bleeding
Leakage of Cardiac Device
Keywords: left atrial appendage occlusion
peri-device leakage
stroke
Lead sponsor: Cardiovascular Center Frankfurt
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after interventional or surgical left atrial appendage occlusion with severe leakage, who underwent interventional peri-device leakage closure

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.

Eligibility 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

Primary outcomes:
measure: Procedural mortality
timeFrame: In-hospital stay, assessed up to 30days
measure: Procedure-related clinically relevant pericardial effusion
timeFrame: In-hospital stay, assessed up to 30days
measure: Procedure-related ischemic stroke
timeFrame: In-hospital stay, assessed up to 30days
Secondary outcomes:
measure: Bleeding complications
timeFrame: through study completion, an average of 1 year
measure: Vascular access site complications
timeFrame: during procedure, assessed up to 7 days
measure: Liver- and kidney failure associated with the procedure
timeFrame: In-hospital stay, assessed up to 30days
measure: Device-associated complications
timeFrame: through study completion, an average of 1 year
measure: Ischemic stroke or transitory ischemic attack
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: • Banner University Medical Center Phoenix
state: Arizona
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute
state: Kansas
city: Rochester
country: United States
facility: Mayo Clinic Hospital - Saint Mary's Campus
state: Minnesota
city: Nashville
country: United States
facility: Vanderbilt Heart Institute
state: Tennessee
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet Copenhagen
city: Frankfurt
country: Germany
facility: Cardio Vascular Center Frankfurt
state: Hesse
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
state: North Rhine-Westphalia
city: Berlin
country: Germany
facility: Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Headington
country: United Kingdom
facility: Nuffield Health
Study officials:
affiliation: University Hospital Düsseldorf and Cardio Vascular Center Frankfurt
name: Kerstin Piayda
role: STUDY_CHAIR
References: