Sentinel(TM) Post-Market Registry

Claret Medical

Status: Completed

Conditions: Severe Symptomatic Calcified Native Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement

Treatments: Device: SENTINEL (Cerebral Protection System)

Study type: Observational

Funder types: Industry

Identifiers

NCT02255851

CP10879

Details and patient eligibility

About

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 TAVR.

Subjects enrolled in the registry will undergo TAVR + Sentinel. Basic demographic information and detailed procedural data will be captured and documented in a registry case report form.

All Sentinel filters will be sent for histopathology at an independent core-lab.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Approved indications for commercially available CE-Marked TAVR devices.
2. Compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15 mm) diameters without significant stenosis (> 70%).
3. 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 criteria

1. Vasculature in the right extremity precluding 6Fr sheath radial/brachial access
2. Inadequate circulation to the right extremity as evidenced by signs of artery occlusion or absence of radial or brachial pulse
3. Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
4. Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion
5. Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel device access and insertion
6. Patient whose brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium
7. Currently participating in an investigational drug or investigational (non CE-mark) device study

Trial design

300 participants in 1 patient group

Treatment Group

Description:

TAVR + SENTINEL (Cerebral Protection System)

Treatment:

Device: SENTINEL (Cerebral Protection System)