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

Not Applicable

Recruiting

• Conditions: Non-Valvular Atrial Fibrillation
• Interventions: Device: Omega™LAA Occluder implantation

• Registration Number: NCT04829929
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2020-11-17
• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-04-01
• Study First Posted: 2021-04-02
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-13
• Primary Completion: 2023-05-30
• Study Completion: 2023-11-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One arm	Omega™LAA Occluder implantation	Patients with Non-Valvular Atrial Fibrillation and High Bleeding Risk

Primary Outcome Measures

Name	Time	Method
Device related complications	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)
LAA (Left Atrial Appendage) closure	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

Secondary Outcome Measures

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

Trial Locations

Locations (9)

University Hospitals Sussex NHS Foundation Trust Clinical Research Facility; 🇬🇧 Brighton, East Sussex, United Kingdom

Charité - University Medicine Berlin - Campus Benjamin Franklin; 🇩🇪 Berlin, Hindenburgdamm 30, 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

Cardioangiologisches Centrum Bethanien; 🇩🇪 Frankfurt, Wilhelm-Epstein-Str. 4, Germany

Rigshospitalet, Kardiologisk klinik B 2011; 🇩🇰 København, Blegdamsvej 9, Denmark

Complejo Hospitalario de Salamanca; 🇪🇸 Salamanca, Junta De Castilla Y LeónPaseo De San Vicente, Spain

Herzzentrum Leipzig; 🇩🇪 Leipzig, Strümpellstraße 39, Germany

CardioVasculäres Centrum, Seckbacher Landstrasse 65; 🇩🇪 Frankfurt, Germany