Evaluation of Safety and Performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in Patients With Non-Valvular Atrial Fibrillation and High Bleeding Risk
NCT ID: NCT04829929
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
200 participants
INTERVENTIONAL
2020-11-17
2027-01-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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One arm
Patients with Non-Valvular Atrial Fibrillation and High Bleeding Risk
Omega™LAA Occluder implantation
Left Atrial Appendage closure for patients with non-valvular atrial fibrillation (NVAF) and high bleeding risk by Omega™LAA Occluder using Omega™ Delivery System
Interventions
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Omega™LAA Occluder implantation
Left Atrial Appendage closure for patients with non-valvular atrial fibrillation (NVAF) and high bleeding risk by Omega™LAA Occluder using Omega™ Delivery System
Eligibility Criteria
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Inclusion Criteria
2. Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF)
3. At increased risk of stroke or systemic embolism defined as a CHA2DS2-VASc score \> or = 2
4. To have suitable anatomy for percutaneous Left Atrial Appendage occlusion procedure with a single Omega™ device
5. Able and willing to comply with the required medication regimen post-device implant
6. Able to understand and willing to provide written informed consent to participate in the study
Exclusion Criteria
2. Contraindicated for or allergic to aspirin, clopidogrel, warfarin or novel oral anticoagulant (NOAC) use
3. Has any contraindications for a percutaneous catheterization procedure (e.g. subject is too small to accommodate the transoesophageal echocardiogram (TEE/TOE) probe or required catheters, or subject has active infection or bleeding disorder)
4. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion)
5. Stroke or transient ischemic attack (TIA) within 6 weeks prior to implant procedure
6. Myocardial infarction (MI) within 90 days prior to implant
7. New York Heart Association Class IV Congestive Heart Failure
8. Left ventricular ejection Fraction (LVEF) \< or = 30%
9. Left atrial appendage is obliterated or surgically ligated
10. Actively enrolled or plans to enrol in a concurrent clinical study in which the active treatment arm may confound the results of this trial
11. Active endocarditis or other infection producing bacteraemia
12. Subject has a known malignancy or other illness where life expectancy is less than 2 years
13. Impaired renal function with eGFR \<30 ml/min/1.73 m2
1. Intracardiac thrombus - including LAA - visualized by echocardiographic imaging
2. Significant mitral valve stenosis (i.e. mitral valve area \<1.5 cm2)
3. Cardiac tumour
4. LAA anatomy cannot accommodate an Omega™ device (as per IFU)
5. Placement of the device would interfere with any intracardiac or intravascular structure.
18 Years
ALL
No
Sponsors
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KCRI
OTHER
Cardiovascular Research Institute Dublin
OTHER
Eclipse Medical Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Horst Sievert, profesor
Role: PRINCIPAL_INVESTIGATOR
Cardio Vasculares Centrum, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany
Locations
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Rigshospitalet, Kardiologisk klinik B 2011
Copenhagen, Blegdamsvej 9, Denmark
Aarhus University Hospital
Aarhus, , Denmark
CardioVasculäres Centrum, Seckbacher Landstrasse 65
Frankfurt, Frankfurt, Germany
Charité - University Medicine Berlin - Campus Benjamin Franklin
Berlin, Hindenburgdamm 30, Germany
Herzzentrum Leipzig
Leipzig, Strümpellstraße 39, Germany
Cardioangiologisches Centrum Bethanien
Frankfurt, Wilhelm-Epstein-Str. 4, Germany
Mater Private Network
Dublin, , Ireland
Università Campus Biomedico Roma
Rome, Via Álvaro Del Portillo, 200, Italy
Instituto de Ciencias del Corazón (ICICOR) . Hospital Clínico Universitario
Valladolid, Avda. Ramón Y Cajal 3, Spain
Hospital Clinico San Carlos
Madrid, Calle Del Prof Martín Lagos, Spain
Complejo Hospitalario de Salamanca
Salamanca, Junta de Castilla Y LeónPaseo de San Vicente, Spain
Hospital de la Santa Creu I Sant Pau
Barcelona, Sant Antoni Maria Clare, Spain
University Hospitals Sussex NHS Foundation Trust Clinical Research Facility
Brighton, East Sussex, United Kingdom
Countries
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References
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De Backer O, Hafiz H, Fabre A, Lertsapcharoen P, Srimahachota S, Foley D, Sondergaard L. State-of-the-art preclinical testing of the OMEGATM left atrial appendage occluder. Catheter Cardiovasc Interv. 2021 Jun 1;97(7):E1011-E1018. doi: 10.1002/ccd.29331. Epub 2020 Oct 9.
Other Identifiers
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Omega
Identifier Type: -
Identifier Source: org_study_id
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