Sentinel(TM) Post-Market Registry

Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02255851

Enrollment

300

Registered

2014-10-03

Start date

2014-03-31

Completion date

2016-05-31

Last updated

2018-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Symptomatic Calcified Native Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement

Keywords

selected for TAVR by heart team consensus, treated with CE-Marked TAVR devices

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 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.

Interventions

DEVICESENTINEL (Cerebral Protection System)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Primary Observational Endpoint	Post-Procedure (day 1)	Capture rate, debris volume and histopathology analysis at day 1.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026