Artrial fibrilation - abnormal heart rhythm
Conditions
Interventions
The implantation procedure is performed under ultrasound (US) guidance by a
single operator under
sterile conditions. The operator holds the US probe in one hand and the
Delivery Device in
the oth
general anesthesia may be
considered at operator
discretion. The time required for deployment in each side of the neck is
expected to be less than one
minute.
The Implant is deployed in the CCA t
Atrial Fibrilation
Sponsors
Javelin Medical Ltd.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Atrial fibrillation (AF) 2. CHA2DS2-VASc score >= 2 3. Age > 50 4. Unsuitable for oral anticoagulation therapy (OAC), defined as contraindicated for OAC, patient refusing OAC, or physician is reluctant to prescribe OAC 5. Maximal (systolic) CCA diameter range: >= 4.8mm and
Exclusion criteria
Exclusion criteria: 1. Evidence of carotid stenosis > 30% [CCA, internal carotid artery (ICA), or external carotid artery (ECA)] 2. Evidence of any atherosclerotic disease in CCA above the clavicles 3. Evidence of carotid dissection 4. Pre-existing stent(s) in CCA 5. Contraindicated or allergic to antiplatelet therapy, or any medication required during the study 6. Recent stroke, TIA, or myocardial infarction (MI) within two months prior to index procedure 7. Female who is pregnant or who is planning to become pregnant during the course of the study 8. Life expectancy of less than 1 year 9. Active systemic infection 10. Known sensitivity to nickel or titanium metals, or their alloys 11. Known hereditary or acquired coagulation disorders 12. Any planned surgical or endovascular procedure within 14 days prior to or 30 days after the index procedure 13. A co-morbid disease or condition that could confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments 14. Current use or a recent history of illicit drug(s) use or alcohol abuse (defined as regular or daily consumption of more than four alcoholic drinks per day) 15. Active participation in another investigational drug or device treatment study 16. Any other condition that in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Primary Safety Endpoints Incidence of device and/or procedure related Major Adverse Events (MAEs) within 30 days of the final index procedure. MAEs are defined as: * Death * Major and minor strokes * Major bleeding * Common carotid artery (CCA) stenosis > 70% * S-3 Implant migration * CCA thrombus * Any complications in the CCA requiring endovascular treatment or surgery -Primary Feasibility Endpoints Procedure success, defined as: * Proper S-3 Implant position in each CCA within 30 days of the final index procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| -Secondary Safety Endpoints - Incidence of device and/or procedure related MAEs within 3, 6, and 12 months of the final index procedure. -Secondary Feasibility Endpoints • Successful delivery and deployment of the Implant in the CCA, defined as proper Implant position within 4 hours of implantation procedure at each CCA • Proper Implant position in each CCA within 3, 6, and 12 months of the final index procedure -Secondary Tolerability Endpoints - Patient*s comfort at Post-procedure visit (Up to 4 hours post implantation), at discharge, and at each follow-up visit | — |
Countries
American Samoa, Belgium, Czechia, Netherlands
Outcome results
None listed