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Clinical Trials in the UK / NCT04829929
Active, not recruiting Not applicable

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

NCT04829929 · tracked via the Priya Life Science UK tracker
Sponsor
Eclipse Medical Ltd.
Phase
Not applicable
Started
2020-11-17
Last updated
2025-12-03

Condition(s) studied

Non-Valvular Atrial Fibrillation

Investigational drug(s) / intervention(s)

Omega™LAA Occluder implantation

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

Study summary

The purpose of the study is to assess the safety and performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in LAA (Left Atrial Appendage) closure for patients with non-valvular atrial fibrillation (NVAF) and high bleeding risk.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. 18 years of age or older 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: 1. Requires long-term oral anticoagulation therapy for any indication other than atrial fibrillation 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 Echocardiographic Exclusion Criteria: 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.

Primary outcome measure(s)

Trial sites (13)

FacilityCityRegionStatus
Rigshospitalet, Kardiologisk klinik B 2011 Copenhagen Blegdamsvej 9
Aarhus University Hospital Aarhus Denmark
CardioVasculäres Centrum, Seckbacher Landstrasse 65 Frankfurt Frankfurt
Charité - University Medicine Berlin - Campus Benjamin Franklin Berlin Hindenburgdamm 30
Herzzentrum Leipzig Leipzig Strümpellstraße 39
Cardioangiologisches Centrum Bethanien Frankfurt Wilhelm-Epstein-Str. 4
Mater Private Network Dublin Ireland
Università Campus Biomedico Roma Rome Via Álvaro Del Portillo, 200
Instituto de Ciencias del Corazón (ICICOR) . Hospital Clínico Universitario Valladolid Avda. Ramón Y Cajal 3
Hospital Clinico San Carlos Madrid Calle Del Prof Martín Lagos
Complejo Hospitalario de Salamanca Salamanca Junta de Castilla Y LeónPaseo de San Vicente
Hospital de la Santa Creu I Sant Pau Barcelona Sant Antoni Maria Clare
University Hospitals Sussex NHS Foundation Trust Clinical Research Facility Brighton East Sussex
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04829929 on ClinicalTrials.gov ↗ ← All trials in the UK