CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 363 enrolled
Drug / intervention
Cerebral Protection System-The SENTINEL System with TAVR +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02214277
NCT02214277N/ACompleted
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Cerebral Protection in Transcatheter Aortic Valve Replacement - The SENTINEL Study

Claret Medical·interventional·Posted Aug 12, 2014·Updated May 11, 2018

In Brief

A clinical study evaluating Cerebral Protection System-The SENTINEL System with TAVR and TAVR for Severe Symptomatic Calcified Native Aortic Valve Stenosis. Completed, enrolled 363 participants across 15 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Symptomatic Calcified Native Aortic Valve Stenosis
CountriesGermany, United States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 12, 2014
Enrollment StartSep 1, 2014
Primary CompletionMar 1, 2016
Study CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.9 years ago

Interventions

Cerebral Protection System-The SENTINEL System with TAVRdevice

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.

TAVRdevice