Vineâ„¢ is a permanent carotid filter designed to provide protection against embolic stroke in people with atrial fibrillation. It is implanted bilaterally in the common carotid arteries from a thin needle under ultrasound guidance. The procedure is performed without general anesthesia and takes minutes. The safety, feasibility and tolerability of Vineâ„¢ will be evaluated. Patients who are eligible will receive Vineâ„¢ and will be followed-up for a year after device implantation.
Who can participate
Age range50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Atrial fibrillation (AF): documented persistent or permanent
✓. CHA2DS2-VASc score ≥ 4
✓. Age \> 50
✓. Unsuitable for oral anticoagulation therapy (OAC), defined as contraindicated for OAC, patient refusing OAC, or physician is reluctant to prescribe OAC
✓. Maximal (systolic) CCA diameter range: ≥ 5.3mm and ≤ 9.8mm
✓. CCA accessibility: up to 60mm from skin to CCA center, safe approach
✓. Patient is willing to provide informed consent
✓. Patient is willing to complete all scheduled follow-up
Exclusion criteria
✕. Evidence of carotid stenosis \> 30% \[CCA, internal carotid artery (ICA), or external carotid artery (ECA)
✕. Evidence of any atherosclerotic disease in CCA above the clavicles
✕. Evidence of carotid dissection
✕. Pre-existing stent(s) in CCA
✕. Contraindicated or allergic to antiplatelet therapy, or any medication required during the study
✕. Recent stroke, TIA, or myocardial infarction (MI) within two months prior to index procedure
What they're measuring
1
Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs)