Peri-device Leakage Closure After LAAO

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04590898
• Other study ID #: CVC-002
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

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

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