Brief Title
Neuroprotection in Patients Undergoing Aortic Valve Replacement
Official Title
Neuroprotection In Patients Undergoing Aortic Valve Replacement
Brief Summary
To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).
Detailed Description
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.
Study Type
Interventional
Primary Outcome
Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction
Secondary Outcome
Number of Participants With a Composite Endpoint of Mortality, Clinical Stroke, and Acute Kidney Injury
Condition
Aortic Stenosis
Intervention
Embol-X Embolic Protection Device
Study Arms / Comparison Groups
Embol-X Embolic Protection Device
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
383
Start Date
March 2015
Completion Date
January 2017
Primary Completion Date
January 2017
Eligibility Criteria
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
Gender
All
Ages
60 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Annetine C Gelijns, PhD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT02389894
Organization ID
GCO 08-1078-0009
Secondary IDs
2U01HL088942-07
Responsible Party
Principal Investigator
Study Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Study Sponsor
Annetine C Gelijns, PhD, Principal Investigator, Icahn School of Medicine at Mount Sinai
Verification Date
April 2019