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

Non-Valvular Atrial Fibrillation Clinical Trial

— Omega  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04829929
• Other study ID #: Omega
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2020
• Est. completion date: November 17, 2023

Study information

• Verified date: December 2022
• Source: Eclipse Medical Ltd.
• Contact: Aidan Mulloy
• Phone: +353 86 2643 765
• Email: aidan[@]eclipse-med.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 17, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Hemorrhage
• Non-Valvular Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Kardiologisk klinik B 2011	København	Blegdamsvej 9
Germany	Charité - University Medicine Berlin - Campus Benjamin Franklin	Berlin	Hindenburgdamm 30
Germany	Cardioangiologisches Centrum Bethanien	Frankfurt	Wilhelm-Epstein-Str. 4
Germany	CardioVasculäres Centrum, Seckbacher Landstrasse 65	Frankfurt
Germany	Herzzentrum Leipzig	Leipzig	Strümpellstraße 39
Italy	Università Campus Biomedico Roma	Rome	Via Álvaro Del Portillo, 200
Spain	Complejo Hospitalario de Salamanca	Salamanca	Junta De Castilla Y LeónPaseo De San Vicente
Spain	Instituto de Ciencias del Corazón (ICICOR) . Hospital Clínico Universitario	Valladolid	Avda. Ramón Y Cajal 3
United Kingdom	University Hospitals Sussex NHS Foundation Trust Clinical Research Facility	Brighton	East Sussex

Sponsors (2)

Lead Sponsor	Collaborator
Eclipse Medical Ltd.	KCRI

Countries where clinical trial is conducted

Denmark,  Germany,  Italy,  Spain,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LAA (Left Atrial Appendage) closure	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	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)
Primary	Device related complications	Serious adverse events (SAE)	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	Procedure-related complications	All Serious Adverse Events	Up to 7 days post-procedure
Secondary	Device-related complications	All Serious Adverse Events including device thrombus	24 months
Secondary	Major bleeding	Major bleeding defined as = BARC (Bleeding Academic Research Consortium) 3 bleed	24 months
Secondary	Ischemic stroke	Confirmed by Neurologic assessment and appropriate CT (Computed Tomography)/MR (Magnetic Resonance) imaging	24 months
Secondary	Systemic embolism	Confirmed by appropriate imaging	24 months
Secondary	Pericardial effusion/tamponade	Confirmed by appropriate imaging	24 months
Secondary	Technical success at implant	No device-related complications, occlusion of the left atrial appendage	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	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 (First in-hospital follow-up visit which will take place around 1-3 months after the procedure - depending on local treatment standards)

External Links

•   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
•   Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints and data collection requirements for clinical studies