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Completed

NCT Number: NCT02255851

Sentinel(TM) Post-Market Registry

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.

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Key information

Conditions

Transcatheter Aortic Valve Replacement Severe Symptomatic Calcified Native Aortic Valve Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

SENTINEL (Cerebral Protection System)

Device

Primary outcomes

  1. Primary Observational Endpoint

    Time frame: Post-Procedure (day 1)

    Capture rate, debris volume and histopathology analysis at day 1.

Sponsors and collaborators

Lead sponsor

Claret Medical

Industry

Registry information

Official study title

Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 3, 2014
Registry last updated
May 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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