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Cerebral Protection in Transcatheter Aortic Valve Replacement

NCT02214277 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 363

Last updated 2018-05-11

Study results available
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Summary

The Sentinel System will be a safe and effective method for capturing and removing embolic material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce the ischemic burden in the cerebral anterior circulation.

Conditions

  • Severe Symptomatic Calcified Native Aortic Valve Stenosis

Interventions

DEVICE

Cerebral Protection System-The SENTINEL System with TAVR

Claret Medical Sentinel Cerebral Protection System is intended for use as an embolic protection system to contain and remove embolic material (thrombus/debris) that may enter the carotid arteries.

DEVICE

TAVR

Sponsors & Collaborators

  • Claret Medical

    lead INDUSTRY

Principal Investigators

  • Susheel Kodali, MD · Columbia University

  • Samir Kapadia, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-03-31
Completion
2016-06-30

Countries

  • United States
  • Germany

Study Locations

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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 NCT02214277 on ClinicalTrials.gov