Evaluation of Safety and Performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega… (NCT04829929) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of Safety and Performance of the Omegaâ„¢ LAA (Left Atrial Appendage) Occluder and Omegaâ„¢ Delivery System in Patients With Non-Valvular Atrial Fibrillation and High Bleeding Risk
The purpose of the study is to assess the safety and performance of the Omegaâ„¢ LAA (Left Atrial Appendage) Occluder and Omegaâ„¢ Delivery System in LAA (Left Atrial Appendage) closure for patients with non-valvular atrial fibrillation (NVAF) and high bleeding risk.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
LAA (Left Atrial Appendage) closure
Timeframe: 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).
2
Device related complications
Timeframe: 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).