Atrial Fibrillation
Conditions
Keywords
AF
Brief summary
Vine™ 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 Vine™ will be evaluated. Patients who are eligible will receive Vine™ and will be followed-up for a year after device implantation.
Detailed description
CAPTURE is a prospective, single-arm, multicenter trial, designed to evaluate the safety, feasibility and tolerability of the Vine™ permanent carotid filter. The trial will enroll up to 30 patients, and will be conducted in up to five sites worldwide. All enrolled patients will be invited for non-invasive follow-up tests and clinical evaluations according to the study protocol.
Interventions
DEVICEVine™
The Vine™ is made of a super-elastic nitinol wire comprises a helix that resides within the CCA lumen and a linear stem that traverses the CCA wall. The helix includes three segments: supporting coils, filter, and leading coils. The device is available in sizes of 6.0mm - 10.0mm (in 0.5mm intervals) to accommodate individual CCA diameters
Sponsors
Javelin Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Multicenter, prospective, non-randomized, open-label, first-in-human (FIH) study
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Atrial fibrillation (AF): documented persistent or permanent 2. CHA2DS2-VASc score ≥ 4 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: ≥ 5.3mm and ≤ 9.8mm 6. CCA accessibility: up to 60mm from skin to CCA center, safe approach 7. Patient is willing to provide informed consent 8. Patient is willing to complete all scheduled follow-up
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 | Description |
|---|---|---|
| Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs) | 30 days from implantation procedure | Major Adverse Events (MAEs) are defined as: * Death * Major and minor strokes * Major bleeding * Common carotid artery (CCA) stenosis \> 70% * Vine™ migration * CCA thrombus * Any complications in the CCA requiring endovascular treatment or surgery |
| Number of patients with Procedure Success | 30 days from implantation procedure | Procedure Success is defined as Proper Vine™ Position in each CCA Proper Vine™ Position is defined as: * Supporting coil in contact with artery walls * No migration * No fracture * No Vine™ coils or portions thereof visible outside the arterial lumen * No entangled or overlapping coils |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with no incidence of device and/or procedure related Major Adverse Events (MAEs) | within 3, 6, months,1, 2, 3, 4 and 5 years of implantation procedure | Death * Major and minor strokes * Major bleeding * Common carotid artery (CCA) stenosis \> 70% * Vine™ migration * CCA thrombus * Any complications in the CCA requiring endovascular treatment or surgery |
| Number of Successful Delivery and Deployment Attempts | within 4 hours of implantation procedure | Successful Delivery and Deployment Attempts is defined as Proper Vine™ Position |
| Number of patients with properly positioned Vine™ in each CCA | within 3, 6, months,1, 2, 3, 4 and 5 years of implantation procedure | Proper implant position |
Countries
Belgium, Czechia, Netherlands
Outcome results
None listed