At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation at High Risk of Stroke and Bleeding Compared to Medical Therapy: a Prospective Randomized Clinical Trial
In Brief
A Phase 4 clinical trial evaluating CE-mark approved LAA closure devices, Acetylsalicylic acid, and 7 other interventions for Atrial Fibrillation. Completed, enrolled 912 participants across 42 sites.
Detailed Summary
The study goal is to determine the clinical benefit of percutaneous catheter-based left atrial appendage (LAA) closure in patients with non-valvular atrial fibrillation (NVAF) at high risk of stroke (CHA2DS2-VASc Score ≥2) as well as high risk of bleeding as compared to best medical care (including a \[non-vitamin K\] oral anticoagulant \[(N)OAC\] when eligible).
Study Details
Timeline
Interventions
LAA closure with post procedure treatment
post procedure treatment according to the physicians (recommendation are made in the protocol); oral anticoagulation is not prescribed in this group
post procedure treatment according to the physicians (recommendation are made in the protocol); oral anticoagulation is not prescribed in this group
Patients allocated to the best medical care group receive either NOAC therapy or VKA
Patients allocated to the best medical care group receive either NOAC therapy or VKA
Patients allocated to the best medical care group receive either NOAC therapy or VKA
Patients allocated to the best medical care group receive either NOAC therapy or VKA
Patients allocated to the best medical care group receive either NOAC therapy or VKA
Patients allocated to the best medical care group receive either NOAC therapy or VKA