Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Eclipse Medical Ltd.
Collaborating Sponsors:
KCRI
Cardiovascular Research Institute Dublin
Conditions:
Non-Valvular Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Omega™ LAA (Left Atrial Appendage) Occluder used in combination with the indicated Omega™ Delivery System is a permanent implant to the left atrial appendage for percutaneous insertion. LLA (Left Atri...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF)
- At increased risk of stroke or systemic embolism defined as a CHA2DS2-VASc score \> or = 2
- To have suitable anatomy for percutaneous Left Atrial Appendage occlusion procedure with a single Omega™ device
- Able and willing to comply with the required medication regimen post-device implant
- Able to understand and willing to provide written informed consent to participate in the study
Exclusion
- Requires long-term oral anticoagulation therapy for any indication other than atrial fibrillation
- Contraindicated for or allergic to aspirin, clopidogrel, warfarin or novel oral anticoagulant (NOAC) use
- 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)
- Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion)
- Stroke or transient ischemic attack (TIA) within 6 weeks prior to implant procedure
- Myocardial infarction (MI) within 90 days prior to implant
- New York Heart Association Class IV Congestive Heart Failure
- Left ventricular ejection Fraction (LVEF) \< or = 30%
- Left atrial appendage is obliterated or surgically ligated
- Actively enrolled or plans to enrol in a concurrent clinical study in which the active treatment arm may confound the results of this trial
- Active endocarditis or other infection producing bacteraemia
- Subject has a known malignancy or other illness where life expectancy is less than 2 years
- Impaired renal function with eGFR \<30 ml/min/1.73 m2
- Echocardiographic
Key Trial Info
Start Date :
November 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04829929
Start Date
November 17 2020
End Date
January 7 2027
Last Update
December 3 2025
Active Locations (13)
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1
Rigshospitalet, Kardiologisk klinik B 2011
Copenhagen, Blegdamsvej 9, Denmark, 2100
2
Aarhus University Hospital
Aarhus, Denmark, DK-8200
3
CardioVasculäres Centrum, Seckbacher Landstrasse 65
Frankfurt, Frankfurt, Germany, 60389
4
Charité - University Medicine Berlin - Campus Benjamin Franklin
Berlin, Hindenburgdamm 30, Germany, 12203 Berlin