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)

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: Active, not recruiting
• Conditions: Non-Valvular Atrial Fibrillation
• Intervention / Treatment: Device: Omega™LAA Occluder implantation

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: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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)	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

Outcome Measure	Measure Description	Time Frame
Procedure-related complications	All Serious Adverse Events	Up to 7 days post-procedure
Device-related complications	All Serious Adverse Events including device thrombus	24 months
Major bleeding	Major bleeding defined as ≥ BARC (Bleeding Academic Research Consortium) 3 bleed	24 months
Ischemic stroke	Confirmed by Neurologic assessment and appropriate CT (Computed Tomography)/MR (Magnetic Resonance) imaging	24 months
Systemic embolism	Confirmed by appropriate imaging	24 months
Pericardial effusion/tamponade	Confirmed by appropriate imaging	24 months
Technical success at implant	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	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

• Sponsor: Eclipse Medical Ltd.
• Collaborators: KCRI; Cardiovascular Research Institute Dublin
• Investigators: Principal Investigator: Horst Sievert, profesor, Cardio Vasculares Centrum, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany

Publications and helpful links

General 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.

Helpful Links

• Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints and data collection requirements for clinical studies
• Impact of clinical and haemodynamic factors on coronary flow reserve and invasive coronary flow capacity in non-obstructed coronary arteries: a patient-level pooled analysis of the DEBATE and ILIAS studies

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2020
• Primary Completion (Actual): February 19, 2025
• Study Completion (Estimated): January 7, 2027

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: left atrial appendage; LAA occluder; non-valvular atrial fibrillation; occluder; high bleeding risk
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Hemorrhage
• Other Study ID 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