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 (Omega)

December 2, 2025 updated by: Eclipse Medical Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Aarhus, Denmark, DK-8200
        • Aarhus University Hospital
    • Blegdamsvej 9
      • Copenhagen, Blegdamsvej 9, Denmark, 2100
        • Rigshospitalet, Kardiologisk klinik B 2011
  • Germany
    • Frankfurt
      • Frankfurt, Frankfurt, Germany, 60389
        • CardioVasculäres Centrum, Seckbacher Landstrasse 65
    • Hindenburgdamm 30
      • Berlin, Hindenburgdamm 30, Germany, 12203 Berlin
        • Charité - University Medicine Berlin - Campus Benjamin Franklin
    • Strümpellstraße 39
      • Leipzig, Strümpellstraße 39, Germany, 04289
        • Herzzentrum Leipzig
    • Wilhelm-Epstein-Str. 4
      • Frankfurt, Wilhelm-Epstein-Str. 4, Germany, 60431
        • Cardioangiologisches Centrum Bethanien
  • Ireland
      • Dublin, Ireland, D07 WKW8
        • Mater Private Network
  • Italy
    • Via Álvaro Del Portillo, 200
      • Rome, Via Álvaro Del Portillo, 200, Italy, 00128
        • Università Campus Biomedico Roma
  • Spain
    • Avda. Ramón Y Cajal 3
      • Valladolid, Avda. Ramón Y Cajal 3, Spain, 47005
        • Instituto de Ciencias del Corazón (ICICOR) . Hospital Clínico Universitario
    • Calle Del Prof Martín Lagos
      • Madrid, Calle Del Prof Martín Lagos, Spain, S/N, 28040
        • Hospital Clinico San Carlos
    • Junta de Castilla Y LeónPaseo de San Vicente
      • Salamanca, Junta de Castilla Y LeónPaseo de San Vicente, Spain, 58-182, 37007
        • Complejo Hospitalario de Salamanca
    • Sant Antoni Maria Clare
      • Barcelona, Sant Antoni Maria Clare, Spain, 08025
        • Hospital de La Santa Creu i Sant Pau
  • United Kingdom
    • East Sussex
      • Brighton, East Sussex, United Kingdom, BN2 1ES
        • University Hospitals Sussex NHS Foundation Trust Clinical Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: One arm
Patients with Non-Valvular Atrial Fibrillation and High Bleeding Risk
Device: Omega™LAA Occluder implantation
Left Atrial Appendage closure for patients with non-valvular atrial fibrillation (NVAF) and high bleeding risk by Omega™LAA Occluder using Omega™ Delivery System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedure-related complications
Time Frame: Up to 7 days post-procedure
All Serious Adverse Events
Up to 7 days post-procedure
Device-related complications
Time Frame: 24 months
All Serious Adverse Events including device thrombus
24 months
Major bleeding
Time Frame: 24 months
Major bleeding defined as ≥ BARC (Bleeding Academic Research Consortium) 3 bleed
24 months
Ischemic stroke
Time Frame: 24 months
Confirmed by Neurologic assessment and appropriate CT (Computed Tomography)/MR (Magnetic Resonance) imaging
24 months
Systemic embolism
Time Frame: 24 months
Confirmed by appropriate imaging
24 months
Pericardial effusion/tamponade
Time Frame: 24 months
Confirmed by appropriate imaging
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).
No device-related complications, occlusion of the left atrial appendage
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).
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
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eclipse Medical Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
KCRI
Cardiovascular Research Institute Dublin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Horst Sievert, profesor, Cardio Vasculares Centrum, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 19, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 7, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Omega

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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