To assess the safety, feasibility, and tolerability of the Vine* Embolic Protection System and implantation procedure in atrial fibrillation (AF) patients at high stroke risk who are unsuitable for oral anti-coagulants (OAC).
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-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 outcome
-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
Background summary
Atrial fibrillation (AF) is a type of irregular heartbeat. These irregular
heartbeats can potentially lead to the formation of a clot, which can travel to
your brain and cause a stroke. Anticoagulants can reduce the stroke risk in AF
patients, but treatment with these drugs is associated with a risk in bleeding
and a lot of patients are not able to take this type of drugs.
The purpose of this study is to investigate whether the Javelin system can be
used in patients with AF who are not suitable for oral anti-coagulants and to
see how safe the system is. This device has never been used in humans before.
Doctors cannot use the device outside a clinical study yet. It has been
previously tested in the laboratory and on animals.
The Javelin System comprises a Delivery Device and a filter (Butterfly Implant)
placed in the artery (CCA) which supplies blood to the head and neck and as
such preventing stroke producing clots from reaching the brain*
Study objective
To assess the safety, feasibility, and tolerability of the Vine* Embolic
Protection System and implantation procedure in atrial fibrillation (AF)
patients at high stroke risk who are unsuitable for oral anti-coagulants (OAC).
Study design
Multicenter, prospective, non-randomized, open-label, first-in-human (FIH)
study.
Intervention
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 other hand. Local anesthesia is recommended; 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 through a 24G needle (0.4 mm inner
diameter). The operator
pierces the CCA wall with the needle, deploys the Implant, and retracts the
needle. The Implant
is automatically deployed from the needle upon operator command.
*
Study burden and risks
The following assessments done during the screening visit: blood drawing,
carotid ultrasound imaging and transthoracic echocardiogram (TTE) would not be
done during standard follow-up of AF. The implantation of the carotid filters
has never been done in humans and is therefore not standard practice. Study
participation requires FU visites during the 4 years following the procedure,
which is more than standard AF treatment. During standard follow-up visits one
would not undergo ultrasound carotid imaging or neurological assessments. This
is only required for the purpose of this study.
5 HaCarmel St. South Industrial Park
Yoqneam Illit 20692
IL
5 HaCarmel St. South Industrial Park
Yoqneam Illit 20692
IL
Listed location countries
Age
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 <= 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61969.100.17 |