NCT02389894|CompletedResultsDMC
Neuroprotection in Patients Undergoing Aortic Valve Replacement
Neuroprotection In Patients Undergoing Aortic Valve Replacement
Loading search results
Sponsor study identifier
Secondary identifiers
interventional
383
2 countries
18
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2017
Actual (reported)Study Completion
January 2017
Actual (reported)To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2017
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.
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
March 10, 2015
Actual (reported)March 17, 2015
Actual (reported)January 2017
Actual (reported)January 2017
Actual (reported)April 29, 2019
Actual (reported)Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction
freedom from CNS infarction, defined as brain, spinal cord, or retinal cell death attributable to ischemia based on neuropathological, neuroimaging, or clinical evidence of permanent injury based on symptoms persisting \> 24 hours, with overt symptoms or no known symptoms. All patients will be assessed by 1.5 T (3.0 T is acceptable if 1.5 T not available) Diffusion-weighted imaging (DWI) at 7 (± 3) days post procedure for presence of brain lesions and to measure the number and volume of any present lesions.
up to 10 days post procedure
Number of Participants With a Composite Endpoint of Mortality, Clinical Stroke, and Acute Kidney Injury
up to 30 days
The surgeon may use either the EMBOL-X® Access Device/Aortic Cannula or a standard cannula with the EMBOL-X® filter deployed through a separate introducer sheath.
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
per the manufacturer's instructions for use (IFU).
CardioGard Cannula, per the manufacturer's instructions for use (IFU).
University of Southern California
Los Angeles, California, 90033, United States
Emory University
Atlanta, Georgia, 30308, United States
University of Maryland
Baltimore, Maryland, 21201, United States
NIH Heart Center at Suburban Hospital
Bethesda, Maryland, 20814, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766, United States
Columbia University Medical Center
New York, New York, 10032, United States
Montefiore Einstein Heart Center
The Bronx, New York, 10467, United States
Messe SR, Overbey JR, Thourani VH, Moskowitz AJ, Gelijns AC, Groh MA, Mack MJ, Ailawadi G, Furie KL, Southerland AM, James ML, Moy CS, Gupta L, Voisine P, Perrault LP, Bowdish ME, Gillinov AM, O'Gara PT, Ouzounian M, Whitson BA, Mullen JC, Miller MA, Gammie JS, Pan S, Erus G, Browndyke JN; Cardiothoracic Surgical Trials Network (CTSN) Investigators. The impact of perioperative stroke and delirium on outcomes after surgical aortic valve replacement. J Thorac Cardiovasc Surg. 2024 Feb;167(2):624-633.e4. doi: 10.1016/j.jtcvs.2022.01.053. Epub 2022 Mar 18.
Crestanello JA. "Not in my brain": The use of embolic protection devices to prevent brain embolization during cardiovascular procedures. J Thorac Cardiovasc Surg. 2018 Dec;156(6):e205-e206. doi: 10.1016/j.jtcvs.2018.05.114. Epub 2018 Jun 23. No abstract available.
Annetine C Gelijns, PhD
Icahn School of Medicine at Mount Sinai
Richard Weisel, MD
Toronto General Hospital
383 participants (actual enrollment reported by the registry).
First Submitted
March 10, 2015
First Posted
March 17, 2015
Study Start
March 2015
Date type not reportedNumber of Patients With Clinically Apparent Stroke at 7 Days
at 7 days
Presence of Radiographic Infarcts
up to 10 days
Total Infarct Volume
Day 7
Decline in Overall Neurocognition
baseline and 90 days
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.
Mission Hospital
Asheville, North Carolina, 28801, United States
Duke University
Durham, North Carolina, 27710, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Baylor Research Institute
Plano, Texas, 75093, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
University of Alberta Hospital
Edmonton, Alberta, T6G2B7, Canada
Toronto General Hospital
Toronto, Ontario, M5B 1W8, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
Québec, Quebec, G1V 4G5, Canada
Mack MJ, Acker MA, Gelijns AC, Overbey JR, Parides MK, Browndyke JN, Groh MA, Moskowitz AJ, Jeffries NO, Ailawadi G, Thourani VH, Moquete EG, Iribarne A, Voisine P, Perrault LP, Bowdish ME, Bilello M, Davatzikos C, Mangusan RF, Winkle RA, Smith PK, Michler RE, Miller MA, O'Sullivan KL, Taddei-Peters WC, Rose EA, Weisel RD, Furie KL, Bagiella E, Moy CS, O'Gara PT, Messe SR; Cardiothoracic Surgical Trials Network (CTSN). Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement: A Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):536-547. doi: 10.1001/jama.2017.9479.
This date has not been verified as actual or estimated.
Primary Completion
January 2017
Actual (reported)Study Completion
January 2017
Actual (reported)Last Updated
April 29, 2019
Results First Posted
April 29, 2019
Record last verified: 2019-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: