Peri-device Leakage Closure After LAAO

Cardiovascular Center Frankfurt

Status: Completed

Conditions: Atrial Fibrillation; Leakage of Cardiac Device; Stroke; Bleeding

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

Study type: Observational

Funder types: Other

Identifiers

NCT04590898

CVC-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

85 participants in 1 patient group

significant peri-device leakage after LAA occlusion

Description:

Peri-device leakage closure after left atrial appendage occlusion

Treatment:

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