Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Icahn School of Medicine at Mount Sinai
With
National Heart, Lung, and Blood Institute (NHLBI)
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.
Age
60–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Neuroprotection in Patients Undergoing Aortic Valve Replacement
