Neuroprotection in Patients Undergoing Aortic Valve Replacement
NCT ID: NCT02389894
Last Updated: 2019-04-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
383 participants
INTERVENTIONAL
2015-03-31
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Embol-X Embolic Protection Device
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.
Embol-X Embolic Protection Device
per the manufacturer's instructions for use (IFU).
CardioGard Cannula
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
CardioGard Cannula
CardioGard Cannula, per the manufacturer's instructions for use (IFU).
Standard Cannula
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
No interventions assigned to this group
Interventions
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Embol-X Embolic Protection Device
per the manufacturer's instructions for use (IFU).
CardioGard Cannula
CardioGard Cannula, per the manufacturer's instructions for use (IFU).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planned and scheduled surgical aortic valve replacement via a full or minimal-access sternotomy (using central aortic perfusion cannulae) for calcific aortic stenosis with a legally marketed valve
* No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization
* Ability to provide informed consent and comply with the protocol
Exclusion Criteria
* History of clinical stroke within 3 months prior to randomization
* Cardiac catheterization within 3 days of the planned aortic valve replacement
* Cerebral and or aortic arch arteriography or interventions within 3 days of the planned aortic valve replacement
* Active endocarditis at time of randomization
* Anticipated inability to tolerate or contraindication for MRI (e.g., known intolerance of MRI, permanent pacemaker at baseline or expected implantation of a permanent pacemaker)
* Any other concomitant aortic procedure such as root replacement
* Concomitant surgical procedures other than CABG, mitral annuloplasty, left atrial appendage (LAA) excision or exclusion, atrial septal defect (ASD) closure or patent foramen ovale (PFO) closure
* Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization
* Concurrent participation in an interventional (drug or device) trial
60 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Annetine Gelijns
Chair, Department of Population Health Science & Policy, Edmond A. Guggenheim Professor of Health Policy Co-Director, InCHOIR
Principal Investigators
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Annetine C Gelijns, PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Richard Weisel, MD
Role: STUDY_CHAIR
Toronto General Hospital
Locations
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University of Southern California
Los Angeles, California, United States
Emory University
Atlanta, Georgia, United States
University of Maryland
Baltimore, Maryland, United States
NIH Heart Center at Suburban Hospital
Bethesda, Maryland, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Columbia University Medical Center
New York, New York, United States
Montefiore Einstein Heart Center
The Bronx, New York, United States
Mission Hospital
Asheville, North Carolina, United States
Duke University
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Baylor Research Institute
Plano, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
University of Alberta Hospital
Edmonton, Alberta, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
Québec, Quebec, Canada
Countries
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References
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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.
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.
Other Identifiers
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GCO 08-1078-0009
Identifier Type: -
Identifier Source: org_study_id
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