Sponsor study identifier
interventional
363
2 countries
15
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2016
Actual (reported)Study Completion
June 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 8, 2014
Actual (reported)August 12, 2014
Actual (reported)September 2014
Date type not reportedThis date has not been verified as actual or estimated.
March 2016
Actual (reported)June 2016
Actual (reported)May 11, 2018
Actual (reported)Reduction in Median Total New Lesion Volume in Protected Territories Between Test and Control Arms as Assessed by DW-MRI at Day 2-7 Post-procedure.
Total new lesion volume is defined as the sum of all diffusion-positive new cerebral lesions in post-TAVR DW-MRI relative to the pre-TAVR DW-MRI scans. Protected territories are defined as brain territories uniquely perfused by the vessels protected by the Sentinel System, namely the left and right carotid arteries, and the right vertebral artery.
Day 2-7 Post-Procedure
Patients With Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days
Primary Safety Endpoint: MACCE (all death, all stroke, and acute kidney injury class 3 within 72 hours or discharge, whatever occurs first) at 30 days compared to a historical performance goal of 18.3%.
30 Days Post-Procedure
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.
Cedars-Sinai Medical Center
Los Angeles, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Morton Plant Hospital
Clearwater, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Henry Ford Hospital
Detroit, Michigan, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Kapadia SR, Kodali S, Makkar R, Mehran R, Lazar RM, Zivadinov R, Dwyer MG, Jilaihawi H, Virmani R, Anwaruddin S, Thourani VH, Nazif T, Mangner N, Woitek F, Krishnaswamy A, Mick S, Chakravarty T, Nakamura M, McCabe JM, Satler L, Zajarias A, Szeto WY, Svensson L, Alu MC, White RM, Kraemer C, Parhizgar A, Leon MB, Linke A; SENTINEL Trial Investigators. Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2017 Jan 31;69(4):367-377. doi: 10.1016/j.jacc.2016.10.023. Epub 2016 Nov 1.
Susheel Kodali, MD
Columbia University
Samir Kapadia, MD
The Cleveland Clinic
363 participants (actual enrollment reported by the registry).
First Submitted
August 8, 2014
First Posted
August 12, 2014
Study Start
September 2014
Date type not reportedThis date has not been verified as actual or estimated.
Captured Debris Histopathology (Observational)
Post-procedure
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
UT Houston / Memorial Hermann
Houston, Texas, United States
UVA Advanced Cardiac Valve Center
Charlottesville, Virginia, United States
UW Medical Center
Seattle, Washington, United States
Herzzentrum Leipzig - Universitatsklinik
Leipzig, 04289, Germany
Primary Completion
March 2016
Actual (reported)Study Completion
June 2016
Actual (reported)Last Updated
May 11, 2018
Results First Posted
May 11, 2018
Record last verified: 2018-04
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Source: ClinicalTrials.gov.
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