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

NCT ID NCT04829929

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

200 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 18 years of age or older 2. Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) 3. At increased risk of stroke or systemic embolism defined as a CHA2DS2-VASc score \> or = 2 4. To have suitable anatomy for percutaneous Left Atrial Appendage occlusion procedure with a single Omega™ device 5. Able and willing to comply with the required medication regimen post-device implant 6. Able to understand and willing to provide written informed consent to participate in the study Exclusion Criteria: 1. Requires long-term oral anticoagulation therapy for any indication other than atrial fibrillation 2. Contraindicated for or allergic to aspirin, clopidogrel, warfarin or novel oral anticoagulant (NOAC) use 3. 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) 4. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion) 5. Stroke or transient ischemic attack (TIA) within 6 weeks prior to implant procedure 6. Myocardial infarction (MI) within 90 days prior to implant 7. New York Heart Association Class IV Congestive Heart Failure 8. Left ventricular ejection Fraction (LVEF) \< or = 30% 9. Left atrial appendage is obliterated or surgically ligated 10. Actively enrolled or plans to enrol in a concurrent clinical study in which the active treatment arm may confound the results of this trial 11. Active endocarditis or other infection producing bacteraemia 12. Subject has a known malignancy or other illness where life expectancy is less than 2 years 13. Impaired renal function with eGFR \<30 ml/min/1.73 m2 Echocardiographic Exclusion Criteria: 1. Intracardiac thrombus - including LAA - visualized by echocardiographic imaging 2. Significant mitral valve stenosis (i.e. mitral valve area \<1.5 cm2) 3. Cardiac tumour 4. LAA anatomy cannot accommodate an Omega™ device (as per IFU) 5. Placement of the device would interfere with any intracardiac or intravascular structure.

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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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