Therapy Strategies After LAA Occluder Device Embolization

• Conditions: Therapy Strategies; Risk Factors; Left Atrial Appendage Occluder; Device Embolisation
• Interventions: Procedure: Removal or leaving of LAA occluders

• Registration Number: NCT05014477
• Lead Sponsor: Cardiovascular Center Frankfurt

Brief 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.

Study Timeline

• Study Start: 2020-09-30
• Study First Submitted: 2021-08-12
• Study First Submitted QC: 2021-08-13
• Study First Posted: 2021-08-20
• Primary Completion: 2021-09-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-22
• Last Update Posted: 2022-07-26
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients after interventional or surgical left atrial appendage occlusion with device embolization

Exclusion Criteria

• n/a

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients experiencing device embolization after left atrial appendage occlusion	Removal or leaving of LAA occluders	Device embolization following either surgical or interventional left atrial appendage occlusion

Primary Outcome Measures

Name	Time	Method
Catheter-based retrieval of LAA Occluder	up to 5 years (after device implantation)	peri-procedural device removal
Need for cardiac surgery	In-hospital stay, assessed up to 30 days
Procedural mortality	In-hospital stay, assessed up to 30 days	all-cause mortality during the index procedure, any procedure-related death within 30days or during in-hospital stay for the index procedure (if\>30days)

Secondary Outcome Measures

Name	Time	Method
Further complications	up to 5 years (after device implantation)	Any other complications after device embolization (i.e., thromboembolic events, circulatory problems, CPR etc.)
Risk factors	up to 30 days (after device implantation)	Favoring conditions for LAAO device dislocation (e.g., anatomical risk factors, risk factors related to the initial procedure)

Trial Locations

Locations (1)

CardioVascular Center (CVC) Frankfurt; 🇩🇪 Frankfurt on the Main, Hesse, Germany