Therapy Strategies After LAA Occluder Device Embolization (LAAODE)

Cardiovascular Center Frankfurt

Status: Active, not recruiting

Conditions: Device Embolisation; Risk Factors; Left Atrial Appendage Occluder; Therapy Strategies

Treatments: Procedure: Removal or leaving of LAA occluders

Study type: Observational

Funder types: Other

Identifiers

NCT05014477

CVC-003

Details and patient eligibility

About

The investigators thought to evaluate risk factors, therapeutic approaches and outcomes after left atrial appendage occluder device embolization (LAAO, either surgical or interventional).

Full description

The global burden of atrial fibrillation (AF) is high, and AF represents a major cause of morbidity, mortality and health-care expenditure. Thromboembolic stroke may be one of the fatal complications and oral anticoagulation has been the mainstay therapy for decades to mitigate stroke risk. However, in poor candidates for long-term anticoagulation (i.e. high bleeding risk, poor drug tolerance or adherence), non- pharmacological stroke prevention with percutaneous left atrial appendage occlusion (LAAO) is a considerable treatment option.

Occluders are implanted into the left atrial appendage (LAA) but they might dislocate and therefore embolize subsequently. In this case, surgical or percutaneous removal of the device may be indicated. Depending on the patient's status, implanting another device can be an alternative to returning to anticoagulation.

Enrollment: 400 estimated 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 device embolization

Exclusion criteria

• n/a

Trial design

400 participants in 1 patient group

Patients experiencing device embolization after left atrial appendage occlusion

Description:

Device embolization following either surgical or interventional left atrial appendage occlusion

Treatment:

Procedure: Removal or leaving of LAA occluders