This study will assess the safety and performance of the Vine™ Embolic Protection System (embolic filtering device) in atrial fibrillation (AF) patients on top of oral anticoagulants (OAC), and remain at high risk for stroke recurrence. All patients will receive bilateral implants in the common carotid arteries
The Vine™ filter (Vine™ or implant) is a permanent carotid filter designed for stroke prevention in AF patients taking OAC at high stroke risk (CHA2DS2-VASc ≤ 4 and stroke history). This patient population accounts for \~20% of the entire AF population, which is \~300K/year in the United State and EU. The implant is designed to exclude emboli \> 1.4mm in size from reaching the anterior circulation. In AF patients, approximately 80% of strokes are total or partial anterior circulation strokes caused by occlusions of the main branches of the Circle of Willis, mainly M1-2, and rarely A1-2. The diameter of these branches, in the majority of cases, is \> 1.5 mm
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
100
The system includes the implant and the Vine™ Inserter (inserter) manufactured by Javelin Medical LTD (Israel). The inserter comprises a Motor Unit and a Needle Unit ("Needle Unit") available in two sizes. The system is operable when the Needle Unit is loaded with the implant (labeled "Loaded Needle Unit") and connected to the Motor Unit. A flag indicating the needle orientation is attached to the needle luer. The implant is automatically deployed from the needle upon activation of the operating button.
OLV Ziekenhuis
Aalst, Belgium
ZNA Stuivenberg
Antwerp, Belgium
Na Homolce Hospital
Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or implantation procedure complications
Major Adverse Events (MAEs) within 30 days of the final index (implantation) procedure, defined as the composite that includes any of the following: * Any ischemic stroke with ischemic foci confined to the territories of Vine™ implanted arteries * Hemorrhagic stroke or major hemorrhage while receiving additional antithrombotic therapy required for Vine™ implantation * Any Vine™ or Vine™ implantation procedure-related complication that requires surgery or endovascular treatment, or results in death or major disability
Time frame: 30 days from implantation procedure
Number of participants that had Ischemic Stroke and/or Hemorrhagic stroke and/or Device complications.
* Any ischemic stroke with ischemic foci confined to the territories of Vine™ implanted arteries * Hemorrhagic stroke or major hemorrhage while receiving additional antithrombotic therapy required for Vine™ implantation * Any Vine™ or Vine™ implantation procedure-related complication that requires surgery or endovascular treatment, or results in death or major disability
Time frame: one and two years from implantation procedure
Number of properly positioned implants
proper implant position in each common carotid artery (CCA)
Time frame: 30 days from implantation procedure
Number of participants that had disabling strokes
Disabling stroke
Time frame: 30 days, one and two years from implantation procedure
Number of Implantation success
implantation attempt resulting in proper implant position immediately after the procedure without any device/procedure related complication that requires surgery or endovascular treatment for correction, or that results in death or major disability
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Prague, Czechia
Alfried-Krupp Krankenhaus Rüttenscheid
Essen, Germany
Cardio Vasculäres Centrum Frankfurt
Frankfurt, Germany
Cardioangiologisches Centrum Bethanien
Frankfurt, Germany
General Hospital of Athens "Hippokrateio"
Athens, Greece
Laiko Hospital
Athens, Greece
University General Hospital of Larisa
Larissa, Greece
European Interbalkan Medical Center
Thessaloniki, Greece
...and 7 more locations
Time frame: immediately after the procedure
Number of properly positioned implants
Proper implant position in each CCA
Time frame: one and two years from implantation procedure
Number of observed thrombi on the device
Thrombus on implant detected by ultrasound imaging
Time frame: 30 days, one and two years from implantation procedure
Number of death cases
Death
Time frame: one and two years from implantation procedure
Number of strokes (any kind)
Total number of strokes
Time frame: one and two years from implantation procedure