NCT05014477

Therapy Strategies After LAA Occluder Device Embolization

Device Embolization After Percutaneous Left Atrial Appendage Occlusion: Risk Factors, Approaches and Outcomes

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Cardiovascular Center Frankfurt · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Left Atrial Appendage Occluder
• Device Embolisation
• Therapy Strategies
• Risk Factors

Interventions

Type	Name	Description
PROCEDURE	Removal or leaving of LAA occluders	After LAA device embolization there are different approaches to dealing with the occluder dislocation. The aim is to find out which way leads to the best outcomes.

Timeline

• Start date: 2020-09-30
• Primary completion: 2021-09-30
• Completion: 2023-12-31
• First posted: 2021-08-20
• Last updated: 2022-07-26

Locations

1 site across 1 country: Germany