Non-Valvular Atrial Fibrillation
Conditions
Keywords
non-valvular atrial fibrillation, left atrial appendage, occluder, LAA occluder, high bleeding risk
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.
Interventions
DEVICEOmega™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
Sponsors
KCRI
Cardiovascular Research Institute Dublin
Eclipse Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 a CHA2DS2-VASc score \> or = 2 4. To have suitable anatomy for percutaneous Left Atrial Appendage occlusion procedure with a single Omega™ device 5. Able and willing to comply with the required medication regimen post-device implant 6. Able to understand and willing to provide written informed consent to participate in the study
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. 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) 4. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion) 5. Stroke or transient ischemic attack (TIA) within 6 weeks prior to implant procedure 6. Myocardial infarction (MI) within 90 days prior to implant 7. New York Heart Association Class IV Congestive Heart Failure 8. Left ventricular ejection Fraction (LVEF) \< or = 30% 9. Left atrial appendage is obliterated or surgically ligated 10. Actively enrolled or plans to enrol in a concurrent clinical study in which the active treatment arm may confound the results of this trial 11. Active endocarditis or other infection producing bacteraemia 12. Subject has a known malignancy or other illness where life expectancy is less than 2 years 13. Impaired renal function with eGFR \<30 ml/min/1.73 m2 Echocardiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LAA (Left Atrial Appendage) closure | According to the local standards of care post-procedural, up to 3 months (First in-hospital follow-up visit which will take place after the procedure - depending on local treatment standards). | The LAA 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, with colour flow Doppler. |
| Device related complications | According to the local standards of care post-procedural, up to 3 months (First in-hospital follow-up visit which will take place around after the procedure - depending on local treatment standards). | Serious adverse events (SAE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Systemic embolism | 24 months | Confirmed by appropriate imaging |
| Procedure-related complications | Up to 7 days post-procedure | All Serious Adverse Events |
| Technical success at implant | According to the local standards of care post-procedural, up to 3 months (First in-hospital follow-up visit which will take place around 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, up to 3 months (First in-hospital follow-up visit which will take place around 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 |
| Pericardial effusion/tamponade | 24 months | Confirmed by appropriate imaging |
| Device-related complications | 24 months | All Serious Adverse Events including device thrombus |
Countries
Denmark, Germany, Ireland, Italy, Spain, United Kingdom
Outcome results
None listed