New device could offer stroke prevention without blood thinners for heart patients
NCT ID NCT04829929
First seen Jan 04, 2026 · Last updated Jun 24, 2026 · Updated 24 times
Summary
This study is testing a device called the Omega™ LAA Occluder in 200 people with non-valvular atrial fibrillation who are at high risk for bleeding. The device is implanted to seal off the left atrial appendage, a small pouch in the heart where clots often form. The goal is to reduce stroke risk without needing long-term blood thinners. Participants will be followed to see if the device safely and effectively closes the appendage and prevents complications.
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Contacts and locations
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Locations
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Aarhus University Hospital
Aarhus, DK-8200, Denmark
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CardioVasculäres Centrum, Seckbacher Landstrasse 65
Frankfurt, Frankfurt, 60389, Germany
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Cardioangiologisches Centrum Bethanien
Frankfurt, Wilhelm-Epstein-Str. 4, 60431, Germany
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Charité - University Medicine Berlin - Campus Benjamin Franklin
Berlin, Hindenburgdamm 30, 12203 Berlin, Germany
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Complejo Hospitalario de Salamanca
Salamanca, Junta de Castilla Y LeónPaseo de San Vicente, 58-182, 37007, Spain
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Herzzentrum Leipzig
Leipzig, Strümpellstraße 39, 04289, Germany
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Hospital Clinico San Carlos
Madrid, Calle Del Prof Martín Lagos, S/N, 28040, Spain
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Hospital de la Santa Creu I Sant Pau
Barcelona, Sant Antoni Maria Clare, 08025, Spain
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Instituto de Ciencias del Corazón (ICICOR) . Hospital Clínico Universitario
Valladolid, Avda. Ramón Y Cajal 3, 47005, Spain
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Mater Private Network
Dublin, D07 WKW8, Ireland
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Rigshospitalet, Kardiologisk klinik B 2011
Copenhagen, Blegdamsvej 9, 2100, Denmark
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University Hospitals Sussex NHS Foundation Trust Clinical Research Facility
Brighton, East Sussex, BN2 1ES, United Kingdom
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Università Campus Biomedico Roma
Rome, Via Álvaro Del Portillo, 200, 00128, Italy
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
Omega™ Left Atrial Appendage Occluder (a device implanted to seal off the left atrial appendage)
What this could lead to
If successful, this device could offer a safer way to prevent strokes in people with atrial fibrillation who cannot take long-term blood thinners.
What could go wrong
This is a single-arm study with no comparison group, so results may be less definitive. Device implantation carries risks like bleeding, infection, or device-related clots.
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.