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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04590898
Other study ID # CVC-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 27, 2020
Est. completion date September 1, 2021

Study information

Verified date July 2022
Source Cardiovascular Center Frankfurt
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date September 1, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Intervention

Device:
Peri-device leakage closure after left atrial appendage occlusion
Peri-device leakage closure after left atrial appendage occlusion

Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus
Denmark Rigshospitalet Copenhagen Copenhagen
Germany Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF) Berlin
Germany Universitätsklinikum Düsseldorf Düsseldorf North Rhine-Westphalia
Germany Cardio Vascular Center Frankfurt Frankfurt Hesse
Poland Poznan University of Medical Sciences Poznan
Spain Hospital Universitario de Salamanca Salamanca
Switzerland Inselspital Bern Bern
United Kingdom Nuffield Health Headington
United States Austin Heart Austin Texas
United States Scripps Health La Jolla California
United States Vanderbilt Heart Institute Nashville Tennessee
United States Kansas City Heart Rhythm Institute Overland Park Kansas
United States • Banner University Medical Center Phoenix Phoenix Arizona
United States Mayo Clinic Hospital - Saint Mary's Campus Rochester Minnesota
United States University of Utah Hospital Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
Cardiovascular Center Frankfurt

Countries where clinical trial is conducted

United States,  Denmark,  Germany,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Procedural mortality 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) In-hospital stay, assessed up to 30days
Primary Procedure-related clinically relevant pericardial effusion 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 In-hospital stay, assessed up to 30days
Primary Procedure-related ischemic stroke 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 In-hospital stay, assessed up to 30days
Secondary Bleeding complications 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) through study completion, an average of 1 year
Secondary Vascular access site complications 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 during procedure, assessed up to 7 days
Secondary Liver- and kidney failure associated with the procedure 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 In-hospital stay, assessed up to 30days
Secondary Device-associated complications Number of participants experiencingdevice migration, perforation, laceration, erosion, device infection, pericarditis, device-related thrombus and persistent or occurrence of new peri-device leakage through study completion, an average of 1 year
Secondary Ischemic stroke or transitory ischemic attack 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 through study completion, an average of 1 year
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