Clinical trial NCT04829929: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Valvular Atrial Fibrillation
Keywords: non-valvular atrial fibrillation
left atrial appendage
occluder
LAA occluder
high bleeding risk
Lead sponsor: Eclipse Medical Ltd.
Sponsor class: INDUSTRY
Collaborators: name: KCRI
First posted: 2021-04-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: LAA (Left Atrial Appendage) closure
timeFrame: 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)
measure: Device related complications
timeFrame: 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)
Secondary outcomes:
measure: Procedure-related complications
timeFrame: Up to 7 days post-procedure
measure: Device-related complications
timeFrame: 24 months
measure: Major bleeding
timeFrame: 24 months
measure: Ischemic stroke
timeFrame: 24 months
measure: Systemic embolism
timeFrame: 24 months
measure: Pericardial effusion/tamponade
timeFrame: 24 months
measure: Technical success at implant
timeFrame: 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)
measure: Procedural success
timeFrame: 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)
Other outcomes:
Locations:
city: København
country: Denmark
facility: Rigshospitalet, Kardiologisk klinik B 2011
state: Blegdamsvej 9
city: Berlin
country: Germany
facility: Charité - University Medicine Berlin - Campus Benjamin Franklin
state: Hindenburgdamm 30
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
state: Strümpellstraße 39
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien
state: Wilhelm-Epstein-Str. 4
city: Frankfurt
country: Germany
facility: CardioVasculäres Centrum, Seckbacher Landstrasse 65
city: Rome
country: Italy
facility: Università Campus Biomedico Roma
state: Via Álvaro Del Portillo, 200
city: Valladolid
country: Spain
facility: Instituto de Ciencias del Corazón (ICICOR) . Hospital Clínico Universitario
state: Avda. Ramón Y Cajal 3
city: Salamanca
country: Spain
facility: Complejo Hospitalario de Salamanca
state: Junta De Castilla Y LeónPaseo De San Vicente
city: Brighton
country: United Kingdom
facility: University Hospitals Sussex NHS Foundation Trust Clinical Research Facility
state: East Sussex
Study officials:
affiliation: Cardio Vasculares Centrum, Seckbacher Landstrasse 65, 60389 Frankfurt, Germany
name: Horst Sievert, profesor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.