Neuroprotection in Patients Undergoing Aortic Valve Replacement

Completed · Not applicable

Conditions studied: Aortic Stenosis, Brain Infarction, Cerebrovascular Accident, Stroke

In brief

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

Key facts

Study ID

NCT02389894

Run by

Icahn School of Medicine at Mount Sinai

People needed

383

Starts

2015-03-01

Expected to finish

2017-01-01

Last updated by the study team

2019-04-29

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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