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Evaluation od 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)

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ClinicalTrials.gov Identifier: NCT04829929
Recruitment Status : Recruiting
First Posted : April 2, 2021
Last Update Posted : April 2, 2021
Sponsor:
Information provided by (Responsible Party):
Eclipse Medical Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Non-Valvular Atrial Fibrillation Device: Omega™LAA Occluder implantation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Single-arm Study to Assess the Safety and Performance of the Omega™ Left Atrial Appendage (LAA) Occluder and Omega™ Delivery System in Patients With Non-Valvular Atrial Fibrillation and High Bleeding Risk
Actual Study Start Date : November 17, 2020
Estimated Primary Completion Date : March 17, 2022
Estimated Study Completion Date : November 17, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. LAA (Left Atrial Appendage) closure [ Time Frame: According to the local standards of care post-procedural (First in-hospital follow-up visit which will take place around 1-3 months after the procedure - depending on local treatment standards) ]
    The 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

  2. Device related complications [ Time Frame: According to the local standards of care post-procedural (First in-hospital follow-up visit which will take place around 1-3 months after the procedure - depending on local treatment standards) ]
    Serious adverse events (SAE)


Secondary Outcome Measures :
  1. Procedure-related complications [ Time Frame: Up to 7 days post-procedure ]
    All Serious Adverse Events

  2. Device-related complications [ Time Frame: 24 months ]
    All Serious Adverse Events including device thrombus

  3. Major bleeding [ Time Frame: 24 months ]
    Major bleeding defined as ≥ BARC (Bleeding Academic Research Consortium) 3 bleed

  4. Ischemic stroke [ Time Frame: 24 months ]
    Confirmed by Neurologic assessment and appropriate CT (Computed Tomography)/MR (Magnetic Resonance) imaging

  5. Systemic embolism [ Time Frame: 24 months ]
    Confirmed by appropriate imaging

  6. Pericardial effusion/tamponade [ Time Frame: 24 months ]
    Confirmed by appropriate imaging

  7. Technical success at implant [ Time Frame: According to the local standards of care post-procedural (First in-hospital follow-up visit which will take place around 1-3 months after the procedure - depending on local treatment standards) ]
    No device-related complications, occlusion of the left atrial appendage

  8. Procedural success [ Time Frame: According to the local standards of care post-procedural (First in-hospital follow-up visit which will take place around 1-3 months 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 CHADS2 score (Risk of Stroke with AF". VA Palo Alto Medical Center and at Stanford University: the Sportsmedicine Program and the Cardiomyopathy Clinic: Congestive/Hypertension/Age/Diabetes/Stroke): ≥ 2 or a CHA2DS2-VASc score (Congestive/Hypertension/Age/Diabetes/Stroke/Vascular disease/Sex) ≥ 3
  4. Deemed, by investigator, to be unsuitable or contraindicated for long term oral anticoagulation therapy due to high bleeding risk
  5. To have suitable anatomy for percutaneous Left Atrial Appendage occlusion procedure with a single Omega™ device
  6. Able and willing to comply with the required medication regimen post-device implant
  7. Able to understand and willing to provide written informed consent to participate in the study
  8. Able to and willing to return for required follow-up visits and examinations.

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. Implanted with a mechanical heart valve prosthesis thus requiring long term oral anticoagulation
  4. 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)
  5. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion)
  6. Stroke or transient ischemic attack (TIA) within 6 weeks prior to implant procedure
  7. Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to implant, or intervention or surgery is planned within 60 days after implant procedure
  8. Myocardial infarction (MI) within 90 days prior to implant
  9. New York Heart Association Class IV Congestive Heart Failure
  10. Left ventricular ejection Fraction (LVEF) ≤ 30%
  11. Reversible cause of AF (i.e. secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
  12. Left atrial appendage is obliterated or surgically ligated
  13. Resting heart rate >110 bpm
  14. Thrombocytopenia (defined as < 70,000 platelets/mm3) or anaemia with haemoglobin concentration of < 10 g/dl (i.e. anaemia as determined by the investigator which would require transfusion)
  15. Actively enrolled or plans to enrol in a concurrent clinical study in which the active treatment arm may confound the results of this trial
  16. Active endocarditis or other infection producing bacteraemia
  17. Subject has a known malignancy or other illness where life expectancy is less than 2 years
  18. Impaired renal function with eGFR (Estimated Glomerular Filtration Rate) <40 ml/min/1.73 m2
  19. More than mild hepatic failure, i.e. ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), or Alkalic Phosphatase >2× upper limit of normal

Echocardiographic Exclusion Criteria:

  1. Intracardiac thrombus - including Left Atrial Appendage - visualized by echocardiographic imaging
  2. Existing circumferential pericardial effusion >2mm
  3. Significant mitral valve stenosis (i.e. mitral valve area <1.5 cm2)
  4. High risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (atrial septal excursion >15mm; excursion defined as maximal protrusion of the ASA (Atrial Septal Aneurysm) beyond the plane of the atrial septum during cardiac cycle) or large shunt (substantial passage of bubbles, i.e. ≥ 25, within 3 cardiac cycles from appearing in the right atrium)
  5. Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
  6. Cardiac tumour
  7. Left Atrial Appendage anatomy cannot accommodate an Omega™ device (as per IFU)
  8. Placement of the device would interfere with any intracardiac or intravascular structure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04829929


Contacts
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Contact: Aidan Mulloy +353 86 2643 765 aidan@eclipse-med.com

Locations
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Denmark
Rigshospitalet, Kardiologisk klinik B 2011 Recruiting
København, Denmark, 2100
Contact: Ole de Backer, MD, PhD       ole.de.backer@regionh.dk   
Sponsors and Collaborators
Eclipse Medical Ltd.
Investigators
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Principal Investigator: Horst Sievert, profesor Cardio Vasculares Centrum, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany
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Responsible Party: Eclipse Medical Ltd.
ClinicalTrials.gov Identifier: NCT04829929    
Other Study ID Numbers: Omega
First Posted: April 2, 2021    Key Record Dates
Last Update Posted: April 2, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eclipse Medical Ltd.:
non-valvular atrial fibrillation
left atrial appendage
occluder
LAA occluder
high bleeding risk
Additional relevant MeSH terms:
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Atrial Fibrillation
Hemorrhage
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes