Status:
COMPLETED
Sentinel(TM) Post-Market Registry
Lead Sponsor:
Claret Medical
Conditions:
Transcatheter Aortic Valve Replacement
Severe Symptomatic Calcified Native Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for ...
Eligibility Criteria
Inclusion
- Approved indications for commercially available CE-Marked TAVR devices.
- Compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15 mm) diameters without significant stenosis (\> 70%).
- The subject or the subject's legal representative has been informed of the nature of the registry, agrees to its provisions and has provided written informed consent as approved by the Ethics Committee of the respective site.
Exclusion
- Vasculature in the right extremity precluding 6Fr sheath radial/brachial access
- Inadequate circulation to the right extremity as evidenced by signs of artery occlusion or absence of radial or brachial pulse
- Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
- Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion
- Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel device access and insertion
- Patient whose brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium
- Currently participating in an investigational drug or investigational (non CE-mark) device study
Key Trial Info
Start Date :
March 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT02255851
Start Date
March 1 2014
End Date
May 1 2016
Last Update
May 23 2018
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