Omega
Research type
Research Study
Full title
Prospective, Single-arm Study to Assess the Safety and Performance of the Omega™ Left Atrial Appendage (LAA) Occluder in Patients with Non-Valvular Atrial Fibrillation and High Bleeding Risk
IRAS ID
293866
Contact name
David Hildick-Smith
Contact email
Sponsor organisation
Eclipse Medical Ltd.
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 5 months, 18 days
Research summary
Clinical study to assess the Omega™ Left Atrial Appendage (LAA) Occluder in Patients with atrial fibrillation and high bleeding risk. \n\nThe clinical trial OMEGA is a multicenter study assessing the OMEGA™ LAA (Left Atrial Appendage) Occluder in patients suffering from atrial fibrillation for which usual anticoagulant medications are considered to be not completely safe due to high risk of bleeding. The OMEGA™ device will potentially reduce the risk of blood clot formation in the left atrial appendage and reduce the risk of stroke. \n \n100 patients will participate in this study at up to 10 sites in Europe. Participation in this study is expected to take approximately 24 months in total for each patient and includes four follow up visits. \n \nThe risks of participation in this study is similar to the risk of treatment with other comparable devices (LAA Occluder). \n \nThe Sponsor of the study – Eclipse Medical Ltd. – is paying for conducting the study.
REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0121
Date of REC Opinion
28 Oct 2021
REC opinion
Further Information Favourable Opinion