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
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)
LAA (Left Atrial Appendage) closure — According to the local standards of care post-procedural, up to 3 months (First in-hospital follow-up visit which will take place after the procedure - depending on local treatment standards). The LAA closure is defined as complete seal or efficient seal with a peri-device leak ≤ 5 mm and assessed by Transthoracic or Transoesophageal Echo or cardiac computed tomography, with colour flow Doppler.
Device related complications — According to the local standards of care post-procedural, up to 3 months (First in-hospital follow-up visit which will take place around after the procedure - depending on local treatment standards). Serious adverse events (SAE)
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.
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