Sentinel(TM) Post-Market Registry

Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement

NCT02255851•Claret Medical

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Key Dates

Start Date

March 1, 2014

Primary Completion Date

May 1, 2016

Completion Date

May 1, 2016

Last Updated

May 23, 2018

Enrollment

300

ACTUAL participants

Conditions

Transcatheter Aortic Valve ReplacementSevere Symptomatic Calcified Native Aortic Valve Stenosis

Interventions

SENTINEL (Cerebral Protection System)

DEVICE

Short Versus Long Antiplatelet Therapy After TAVI

NCT06518317

Transcatheter Aortic Valve Replacement

View study

RECRUITING

Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR

NCT04139616

Conduction DisturbancesTranscatheter Aortic Valve Replacement+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Sentinel(TM) Post-Market Registry

Inclusion Criteria

Exclusion Criteria

Short Versus Long Antiplatelet Therapy After TAVI

Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR

Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System

Low-dose Colchicine for Thromboprophylaxis After Transcatheter Aortic Valve Replacement

Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement

The Sentinel Registry