Active — Not RecruitingNot 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

Denmark, Germany, Ireland200 participantsStarted 2020-11-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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).

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).

Trial details

NCT IDNCT04829929

SponsorEclipse Medical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-19

View on ClinicalTrials.gov More Non-Valvular Atrial Fibrillation trials