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
NCT ID: NCT04829929
Last Updated: 2022-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2020-11-17
2023-11-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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One arm
Patients with Non-Valvular Atrial Fibrillation and High Bleeding Risk
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
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.
18 Years
ALL
No
Sponsors
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KCRI
OTHER
Eclipse Medical Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Horst Sievert, profesor
Role: PRINCIPAL_INVESTIGATOR
Cardio Vasculares Centrum, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany
Locations
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Rigshospitalet, Kardiologisk klinik B 2011
Copenhagen, Blegdamsvej 9, Denmark
Charité - University Medicine Berlin - Campus Benjamin Franklin
Berlin, Hindenburgdamm 30, Germany
Herzzentrum Leipzig
Leipzig, Strümpellstraße 39, Germany
Cardioangiologisches Centrum Bethanien
Frankfurt, Wilhelm-Epstein-Str. 4, Germany
CardioVasculäres Centrum, Seckbacher Landstrasse 65
Frankfurt, , Germany
Università Campus Biomedico Roma
Rome, Via Álvaro Del Portillo, 200, Italy
Instituto de Ciencias del Corazón (ICICOR) . Hospital Clínico Universitario
Valladolid, Avda. Ramón Y Cajal 3, Spain
Complejo Hospitalario de Salamanca
Salamanca, Junta de Castilla Y LeónPaseo de San Vicente, Spain
University Hospitals Sussex NHS Foundation Trust Clinical Research Facility
Brighton, East Sussex, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Ole de Backer, MD, PhD
Role: primary
Kirsten Thrysøe
Role: backup
Carsten Skurk, Prof.
Role: primary
Marcus Sandri, PD Dr.
Role: primary
Anne-Kathrin Funkat
Role: backup
Boris Schmidt
Role: primary
Ines Timmermanns
Role: backup
Horst Sievert, Profesor
Role: primary
Sabine de Bruijn
Role: backup
Gian Paolo Ussia, Prof.
Role: primary
Elisabetta Ricottini, Dr.
Role: backup
Ignacio J.Amat-Santos, MD, PhD
Role: primary
Carlos Baladrón Zorita
Role: backup
Ignacio Cruz Gonzalez, MD, PhD
Role: primary
Nuria Sanchez Barbero
Role: backup
David Hildick-Smith
Role: primary
Alison Porges
Role: backup
References
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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.
Related Links
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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
Other Identifiers
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Omega
Identifier Type: -
Identifier Source: org_study_id