Non-Valvular Atrial FibrillationOmegaNCT04829929
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
A study testing Omega™LAA Occluder implantation in people with Non-Valvular Atrial Fibrillation, run by Eclipse Medical Ltd. at 13 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Valvular Atrial Fibrillation
- What is being tested?
- Omega™LAA Occluder implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 13 sitesin 6 countries
- Study dates
- 17 Nov 2020to 7 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Myocardial infarction (MI) within 90 days prior to implant
Show all 19Show fewer
- New York Heart Association Class IV Congestive Heart Failure
- Left ventricular ejection Fraction (LVEF) < or = 30%
- Left atrial appendage is obliterated or surgically ligated
- Actively enrolled or plans to enrol in a concurrent clinical study in which the active treatment arm may confound the results of this trial
- Active endocarditis or other infection producing bacteraemia
- Subject has a known malignancy or other illness where life expectancy is less than 2 years
- Impaired renal function with eGFR <30 ml/min/1.73 m2
- Echocardiographic Exclusion Criteria:
- Intracardiac thrombus - including LAA - visualized by echocardiographic imaging
- Significant mitral valve stenosis (i.e. mitral valve area <1.5 cm2)
- Cardiac tumour
- LAA anatomy cannot accommodate an Omega™ device (as per IFU)
- Placement of the device would interfere with any intracardiac or intravascular structure.
Trial locations and contacts
13 sites in 6 countries.
13 sites in 6 countries
Germany4 sites
Charité - University Medicine Berlin - Campus Benjamin Franklin
Berlin, Hindenburgdamm 30, 12203 Berlin
CardioVasculäres Centrum, Seckbacher Landstrasse 65
Frankfurt, Frankfurt, 60389
Cardioangiologisches Centrum Bethanien
Frankfurt, Wilhelm-Epstein-Str. 4, 60431
Herzzentrum Leipzig
Leipzig, Strümpellstraße 39, 04289
Spain4 sites
Hospital de la Santa Creu I Sant Pau
Barcelona, Sant Antoni Maria Clare, 08025
Hospital Clinico San Carlos
Madrid, Calle Del Prof Martín Lagos, S/N, 28040
Complejo Hospitalario de Salamanca
Salamanca, Junta de Castilla Y LeónPaseo de San Vicente, 58-182, 37007
Instituto de Ciencias del Corazón (ICICOR) . Hospital Clínico Universitario
Valladolid, Avda. Ramón Y Cajal 3, 47005
Denmark2 sites
Aarhus University Hospital
Aarhus, DK-8200
Rigshospitalet, Kardiologisk klinik B 2011
Copenhagen, Blegdamsvej 9, 2100
Italy1 site
Università Campus Biomedico Roma
Rome, Via Álvaro Del Portillo, 200, 00128
United Kingdom1 site
University Hospitals Sussex NHS Foundation Trust Clinical Research Facility
Brighton, East Sussex, BN2 1ES
About this study
Official title: Prospective, Single-arm Study to Assess the Safety and Performance of the Omega™ Left Atrial Appendage (LAA) Occluder 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 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.
Read the detailed description
Omega™ LAA (Left Atrial Appendage) Occluder used in combination with the indicated Omega™ Delivery System is a permanent implant to the left atrial appendage for percutaneous insertion. LLA (Left Atrial Appendage) occlusion appears to be a feasible option for stroke reduction in AF patients at high risk for stroke, who are contraindicated for anticoagulation or who suffered a stroke despite OC. This study will evaluate safety and performance, using a study design which is based on inputs from pre-clinical testing, the risk analysis and data available from other LAA (Left Atrial Appendage) devices.
- Conditions
- Non-Valvular Atrial Fibrillation
- Being tested
- Omega™LAA Occluder implantation
- Keywords
- non-valvular atrial fibrillation, left atrial appendage, occluder, LAA occluder, high bleeding risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega™LAA Occluder implantationDevice
Left Atrial Appendage closure for patients with non-valvular atrial fibrillation (NVAF) and high bleeding risk by Omega™LAA Occluder using Omega™ Delivery System
| Study group | Role | What they receive |
|---|---|---|
| One arm | Experimental | Patients with Non-Valvular Atrial Fibrillation and High Bleeding Risk Receives: Device: Omega™LAA Occluder implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
LAA (Left Atrial Appendage) closure
The LAA closure is defined as complete seal or efficient seal with a peri-device leak ≤ 5 mm and assessed by Transthoracic or Transoesophageal Echo or cardiac computed tomography, with colour flow Doppler.
Measured: 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
Serious adverse events (SAE)
Measured: 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).
Secondary outcomes (8)
Procedure-related complications
All Serious Adverse Events
Measured: Up to 7 days post-procedure
Device-related complications
All Serious Adverse Events including device thrombus
Measured: 24 months
Major bleeding
Major bleeding defined as ≥ BARC (Bleeding Academic Research Consortium) 3 bleed
Measured: 24 months
Ischemic stroke
Confirmed by Neurologic assessment and appropriate CT (Computed Tomography)/MR (Magnetic Resonance) imaging
Measured: 24 months
Systemic embolism
Confirmed by appropriate imaging
Measured: 24 months
Pericardial effusion/tamponade
Confirmed by appropriate imaging
Measured: 24 months
Technical success at implant
No device-related complications, occlusion of the left atrial appendage
Measured: 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).
Procedural success
Technical success, no procedure-related complications except uncomplicated (minor) device embolization resolved by percutaneous retrieval during the procedure without surgical intervention or damage to surrounding cardiovascular structures
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start17 Nov 2020
- Primary completion19 Feb 2025
- Study completion7 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Valvular Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eclipse Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KCRI, Cardiovascular Research Institute Dublin
- Responsible party
- Sponsor
- Investigators
- Horst Sievert, profesor, Principal investigator, Cardio Vasculares Centrum, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829929
- Sponsor's protocol ID
- Omega
- Acronym
- Omega
- Status last verified
- Dec 2025
- First submitted
- 24 Mar 2021
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Backer O, Hafiz H, Fabre A, Lertsapcharoen P, Srimahachota S, Foley D, Sondergaard L. State-of-the-art preclinical testing of the OMEGATM left atrial appendage occluder. Catheter Cardiovasc Interv. 2021 Jun 1;97(7):E1011-E1018. doi: 10.1002/ccd.29331. Epub 2020 Oct 9.
PubMed 33034944
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-arm Study to Assess the Safety and Performance of the Omega™ Left Atrial Appendage (LAA) Occluder in Patients With Non-Valvular Atrial Fibrillation and High Bleeding Risk
- ClinicalTrials.gov ID
- NCT04829929
- Acronym / sponsor ID
- Omega / Omega
- Conditions
- Non-Valvular Atrial Fibrillation
- Keywords
- non-valvular atrial fibrillation, left atrial appendage, occluder, LAA occluder, high bleeding risk
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Eclipse Medical Ltd.Industry (pharma, biotech, devices)
- Collaborators
- KCRI, Cardiovascular Research Institute Dublin
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 7 Jan 2027 (estimated)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Omega™ LAA (Left Atrial Appendage) Occluder used in combination with the indicated Omega™ Delivery System is a permanent implant to the left atrial appendage for percutaneous insertion. LLA (Left Atrial Appendage) occlusion appears to be a feasible option for stroke reduction in AF patients at high risk for stroke, who are contraindicated for anticoagulation or who suffered a stroke despite OC. This study will evaluate safety and performance, using a study design which is based on inputs from pre-clinical testing, the risk analysis and data available from other LAA (Left Atrial Appendage) devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One arm | Experimental | Device: Omega™LAA Occluder implantationPatients with Non-Valvular Atrial Fibrillation and High Bleeding Risk |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega™LAA Occluder implantationLeft Atrial Appendage closure for patients with non-valvular atrial fibrillation (NVAF) and high bleeding risk by Omega™LAA Occluder using Omega™ Delivery System | Device | One arm |
Primary outcome
LAA (Left Atrial Appendage) closure
Time frame: 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).
The LAA closure is defined as complete seal or efficient seal with a peri-device leak ≤ 5 mm and assessed by Transthoracic or Transoesophageal Echo or cardiac computed tomography, with colour flow Doppler.
Device related complications
Time frame: 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).
Serious adverse events (SAE)
8 secondary outcomes
Procedure-related complications
Time frame: Up to 7 days post-procedure
Device-related complications
Time frame: 24 months
Major bleeding
Time frame: 24 months
Ischemic stroke
Time frame: 24 months
Systemic embolism
Time frame: 24 months
Pericardial effusion/tamponade
Time frame: 24 months
Technical success at implant
Time frame: 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).
Procedural success
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Background: PubMed 33034944De Backer O, Hafiz H, Fabre A, Lertsapcharoen P, Srimahachota S, Foley D, Sondergaard L. State-of-the-art preclinical testing of the OMEGATM left atrial appendage occluder. Catheter Cardiovasc Interv. 2021 Jun 1;97(7):E1011-E1018. doi: 10.1002/ccd.29331. Epub 2020 Oct 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horst Sievert, profesor principal investigator
Cardio Vasculares Centrum, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany
13 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega™LAA Occluder implantation in people with Non-Valvular Atrial Fibrillation, run by Eclipse Medical Ltd. at 13 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Spain, Denmark, Ireland, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LAA (Left Atrial Appendage) closure (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04829929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.