Clinical trial NCT02389894: Neuroprotection in Patients Undergoing Aortic Valve Replacement
Official title: Neuroprotection In Patients Undergoing Aortic Valve Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis
Brain Infarction
Cerebrovascular Accident
Stroke
Keywords: Embolic Protection Device
Stroke
Brain Infarction
atheroma
Aortic Valve Replacement
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2015-03-17
Enrollment: 383
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction
timeFrame: up to 10 days post procedure
Secondary outcomes:
measure: Number of Participants With a Composite Endpoint of Mortality, Clinical Stroke, and Acute Kidney Injury
timeFrame: up to 30 days
measure: Number of Patients With Clinically Apparent Stroke at 7 Days
timeFrame: at 7 days
measure: Presence of Radiographic Infarcts
timeFrame: up to 10 days
measure: Total Infarct Volume
timeFrame: Day 7
measure: Decline in Overall Neurocognition
timeFrame: baseline and 90 days
measure: Decline in Neurocognitive Function in the Verbal Memory Domain at 90 Days
timeFrame: baseline and 90 days
measure: Decline in Neurocognitive Function in the Visual Memory Domain at 90 Days
timeFrame: baseline and 90 days
measure: Decline in Neurocognitive Function in the Executive Function Domain at 90 Day
timeFrame: baseline and 90 days
measure: Decline in Neurocognitive Function in the Visuospatial/Constructional Praxis Domain at 90 Days
timeFrame: baseline and 90 days
measure: Decline in Neurocognitive Function in the Auditory-Verbal Simple Attention Domain at 90 Days
timeFrame: baseline and 90 days
measure: Decline in Neurocognitive Function in the Visuomotor/Information Processing Speed Domain at 90 Days
timeFrame: baseline and 90 days
measure: Modified Rankin Scale >2 at 90 Days
timeFrame: 90 days
measure: Barthel Index <= 80
timeFrame: 90 days
measure: Number of Participants With Confusion Assessment Method (CAM) Delirium Assessment at 7 Days
timeFrame: 7 days
measure: Mortality by 90 Days
timeFrame: up to 90 days
measure: Length of Stay for Index Hospitalization
timeFrame: up to 90 days
measure: Hospital Readmissions
timeFrame: up to 90 days
measure: Quality of Life - Physical Health Composite
timeFrame: at 90 days
measure: Quality of Life - Mental Health Composite
timeFrame: at 90 days
measure: Number of Participants With Emboli Captured
timeFrame: day 1
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Bethesda
country: United States
facility: NIH Heart Center at Suburban Hospital
state: Maryland
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Bronx
country: United States
facility: Montefiore Einstein Heart Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Plano
country: United States
facility: Baylor Research Institute
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Annetine C Gelijns, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto General Hospital
name: Richard Weisel, MD
role: STUDY_CHAIR
References:
citation: Crestanello JA. "Not in my brain": The use of embolic protection devices to prevent brain embolization during cardiovascular procedures. J Thorac Cardiovasc Surg. 2018 Dec;156(6):e205-e206. doi: 10.1016/j.jtcvs.2018.05.114. Epub 2018 Jun 23. No abstract available.
citation: Mack MJ, Acker MA, Gelijns AC, Overbey JR, Parides MK, Browndyke JN, Groh MA, Moskowitz AJ, Jeffries NO, Ailawadi G, Thourani VH, Moquete EG, Iribarne A, Voisine P, Perrault LP, Bowdish ME, Bilello M, Davatzikos C, Mangusan RF, Winkle RA, Smith PK, Michler RE, Miller MA, O'Sullivan KL, Taddei-Peters WC, Rose EA, Weisel RD, Furie KL, Bagiella E, Moy CS, O'Gara PT, Messe SR; Cardiothoracic Surgical Trials Network (CTSN). Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement: A Randomized Clinical Trial. JAMA. 2017 Aug 8;318(6):536-547. doi: 10.1001/jama.2017.9479.