Neuroprotection in Patients Undergoing Aortic Valve Replacement



Status:Completed
Conditions:Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:60 - Any
Updated:12/15/2017
Start Date:March 2015
End Date:January 2017

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Neuroprotection In Patients Undergoing Aortic Valve Replacement

To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain
injury in patients undergoing surgical aortic valve replacement (AVR).

This is a multicenter randomized trial in which patients diagnosed with calcific aortic
stenosis (AS) with planned AVR will be randomized to 1) the treatment arm of the Edwards Life
Science filter and cannula or the filter as a stand alone with any cannula or 2) to the
treatment arm of the CardioGard cannula versus 3) standard care in a 1:1:1 ratio.

Inclusion Criteria:

- Age ≥ 60 years

- 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:

- Contraindication to legally marketed embolic protection devices (e.g. aneurysm of the
ascending aorta, aortic trauma, porcelain aorta, known sensitivity to heparin)

- 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
We found this trial at
15
sites
Los Angeles, California 90033
213) 740-2311
Principal Investigator: Michael Bowdish, MD
Phone: 323-409-5573
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Vinod Thourani, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Peter Smith, MD
Phone: 919-684-2037
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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Asheville, North Carolina 28801
Principal Investigator: Mark A Groh, MD
Phone: 828-213-5673
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Asheville, NC
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Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: James S Gammie, MD
Phone: 410-328-4562
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Baltimore, MD
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Bethesda, Maryland 20892
Principal Investigator: Keith Horvath, MD
Phone: 301-896-3775
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Bethesda, MD
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Bronx, New York 10467
Principal Investigator: Robert E. Michler, MD
Phone: 718-920-2221
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Bronx, NY
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Gorav Ailawadi, MD
Phone: 434-243-0315
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Charlottesville, VA
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Nader Moazami, MD
Phone: 216-445-4437
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Bryan Whitson, MD
Phone: 614-688-7904
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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Edmonton, Alberta
Principal Investigator: John C Mullen, MD, MSc
Phone: 780-407-6327
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Edmonton,
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Michael Argenziano, MD
Phone: 212 342 0261
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Michael Acker, MD
Phone: 215-662-7981
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Plano, Texas 75093
Principal Investigator: Michael Mack, MD
Phone: 469-814-4183
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Plano, TX
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