MedTrace Logo

Sentinel(TM) Post-Market Registry

NCT02255851 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2018-05-23

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

SENTINEL (Cerebral Protection System)

Sponsors & Collaborators

  • Claret Medical

    lead INDUSTRY

Principal Investigators

  • Christoph Naber, MD · Elisabeth-Krankenhaus Essen GmbH, Essen, Germany

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-05-31
Completion
2016-05-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02255851 on ClinicalTrials.gov