New device could offer stroke prevention without blood thinners for heart patients

NCT ID NCT04829929

Ongoing Disease control Sponsor: Eclipse Medical Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

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.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

NON-VALVULAR ATRIAL FIBRILLATION

Contacts and locations

Locations

Aarhus University Hospital

Aarhus, DK-8200, Denmark
CardioVasculäres Centrum, Seckbacher Landstrasse 65

Frankfurt, Frankfurt, 60389, Germany
Cardioangiologisches Centrum Bethanien

Frankfurt, Wilhelm-Epstein-Str. 4, 60431, Germany
Charité - University Medicine Berlin - Campus Benjamin Franklin

Berlin, Hindenburgdamm 30, 12203 Berlin, Germany
Complejo Hospitalario de Salamanca

Salamanca, Junta de Castilla Y LeónPaseo de San Vicente, 58-182, 37007, Spain
Herzzentrum Leipzig

Leipzig, Strümpellstraße 39, 04289, Germany
Hospital Clinico San Carlos

Madrid, Calle Del Prof Martín Lagos, S/N, 28040, Spain
Hospital de la Santa Creu I Sant Pau

Barcelona, Sant Antoni Maria Clare, 08025, Spain
Instituto de Ciencias del Corazón (ICICOR) . Hospital Clínico Universitario

Valladolid, Avda. Ramón Y Cajal 3, 47005, Spain
Mater Private Network

Dublin, D07 WKW8, Ireland
Rigshospitalet, Kardiologisk klinik B 2011

Copenhagen, Blegdamsvej 9, 2100, Denmark
University Hospitals Sussex NHS Foundation Trust Clinical Research Facility

Brighton, East Sussex, BN2 1ES, United Kingdom
Università Campus Biomedico Roma

Rome, Via Álvaro Del Portillo, 200, 00128, Italy

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