Neuroprotection in Patients Undergoing Aortic Valve Replacement

Completed

Phase N/A Results N/A

Update History

14 Apr '17
The gender criteria for eligibility was updated to "All."
26 Jul '16
A location was updated in Los Angeles.
New
The overall status was removed for University of Southern California.
A location was updated in Atlanta.
New
The overall status was removed for Emory University.
A location was updated in Baltimore.
New
The overall status was removed for University of Maryland.
A location was updated in Bethesda.
New
The overall status was removed for NIH Heart Center at Suburban Hospital.
A location was updated in Lebanon.
New
The overall status was removed for Dartmouth-Hitchcock Medical Center.
A location was updated in Bronx.
New
The overall status was removed for Montefiore Einstein Heart Center.
A location was updated in New York.
New
The overall status was removed for Columbia University Medical Center.
A location was updated in Asheville.
New
The overall status was removed for Mission Hospital.
A location was updated in Durham.
New
The overall status was removed for Duke University.
A location was updated in Cleveland.
New
The overall status was removed for Cleveland Clinic Foundation.
A location was updated in Columbus.
New
The overall status was removed for Ohio State University.
A location was updated in Philadelphia.
New
The overall status was removed for University of Pennsylvania.
A location was updated in Plano.
New
The overall status was removed for Baylor Research Institute.
A location was updated in Charlottesville.
New
The overall status was removed for University of Virginia.
A location was updated in Edmonton.
New
The overall status was removed for University of Alberta Hospital.
A location was updated in Toronto.
New
The overall status was removed for Toronto General Hospital.
A location was updated in Montreal.
New
The overall status was removed for Montreal Heart Institute.
A location was updated in Quebec.
New
The overall status was removed for Institut Universitaire de Cardiologie de Quebec (Hopital Laval).
24 Feb '16
The minimum age criteria for eligibility was updated to "60 Years."
The eligibility criteria were updated.
New
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
Old
Inclusion Criteria: - Age ≥ 65 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 or expected implantation of a permanent pacemaker) - Any other concomitant aortic procedure such as root replacement - Concomitant surgical procedures other than CABG or mitral annuloplasty - Clinical signs of cardiogenic shock or treatment with IV inotropic therapy at the time of randomization - Concurrent participation in an interventional (drug or device) trial
2 Feb '16
A location was updated in Baltimore.
New
The overall status was removed for University of Maryland.
A location was updated in Lebanon.
New
The overall status was removed for Dartmouth-Hitchcock Medical Center.
A location was updated in Columbus.
New
The overall status was removed for Ohio State University.
16 Dec '15
A location was updated in Toronto.
New
The overall status was removed for Toronto General Hospital.
21 Nov '15
A location was updated in Durham.
New
The overall status was removed for Duke University.
A location was updated in Montreal.
New
The overall status was removed for Montreal Heart Institute.
A location was updated in Quebec.
New
The overall status was removed for Institut Universitaire de Cardiologie de Quebec (Hopital Laval).
17 Oct '15
A location was updated in Cleveland.
New
The overall status was removed for Cleveland Clinic Foundation.
3 Oct '15
The eligibility criteria were updated.
New
Inclusion Criteria: - Age ≥ 65 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 or expected implantation of a permanent pacemaker) - Any other concomitant aortic procedure such as root replacement - Concomitant surgical procedures other than CABG or mitral annuloplasty - Clinical signs of cardiogenic shock or treatment with IV inotropic therapy at the time of randomization - Concurrent participation in an interventional (drug or device) trial
Old
Inclusion Criteria: - Age ≥ 65 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 or expected implantation of a permanent pacemaker) - Any other concomitant aortic procedure such as root replacement - Concomitant surgical procedures other than CABG or mitral annuloplasty - Clinical signs of cardiogenic shock or treatment with IV inotropic therapy at the time of randomization - Concurrent participation in an interventional (drug or device) trial
A location was updated in Bethesda.
New
The overall status was removed for NIH Heart Center at Suburban Hospital.
A location was updated in Bronx.
New
The overall status was removed for Montefiore Einstein Heart Center.
A location was updated in New York.
New
The overall status was removed for Columbia University Medical Center.
17 Jul '15
A location was updated in Los Angeles.
New
The overall status was removed for University of Southern California.
18 Jun '15
A location was updated in Atlanta.
New
The overall status was removed for Emory University.
A location was updated in Charlottesville.
New
The overall status was removed for University of Virginia.
1 May '15
The Summary of Purpose was updated.
New
To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).
Old
To evaluate the efficacy and safety of an embolic protection device to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).
The description was updated.
New
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.
Old
This is a multicenter randomized trial in which patients diagnosed with calcific aortic stenosis (AS) with planned AVR will be randomized to the treatment arm of the Edwards Life Science filter and cannula or the filter as a stand alone with any cannula versus standard care in a 1:1 ratio.
The eligibility criteria were updated.
New
Inclusion Criteria: - Age ≥ 65 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 or expected implantation of a permanent pacemaker) - Any other concomitant aortic procedure such as root replacement - Concomitant surgical procedures other than CABG or mitral annuloplasty - Clinical signs of cardiogenic shock or treatment with IV inotropic therapy at the time of randomization - Concurrent participation in an interventional (drug or device) trial
Old
Inclusion Criteria: - Age ≥ 65 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 Embol-X device (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 or expected implantation of a permanent pacemaker) - Any other concomitant aortic procedure such as root replacement - Concomitant surgical procedures other than CABG or mitral annuloplasty - Clinical signs of cardiogenic shock or treatment with IV inotropic therapy at the time of randomization - Concurrent participation in an interventional (drug or device) trial
A location was updated in Asheville.
New
The overall status was removed for Mission Hospital.
A location was updated in Philadelphia.
New
The overall status was removed for University of Pennsylvania.
A location was updated in Plano.
New
The overall status was removed for Baylor Research Institute.
2 Apr '15
A location was updated in Houston.
New
The overall status was updated to "Recruiting" at Baylor College of Medicine.