Overview

This trial is active, not recruiting.

Conditions aortic stenosis, brain infarction, cerebrovascular accident, stroke
Treatments embol-x embolic protection device, cardiogard cannula
Sponsor Icahn School of Medicine at Mount Sinai
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date March 2015
End date March 2017
Trial size 535 participants
Trial identifier NCT02389894, 2U01HL088942-07, GCO 08-1078-0009

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
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.
embol-x embolic protection device Edwards Embol-X embolic protection device
per the manufacturer's instructions for use (IFU).
(Active Comparator)
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
cardiogard cannula CardioGard Emboli Protection Cannula
CardioGard Cannula, per the manufacturer's instructions for use (IFU).
(No Intervention)
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.

Primary Outcomes

Measure
freedom from clinical or radiographic central nervous system (CNS) infarction
time frame: up to 10 days post procedure

Secondary Outcomes

Measure
A composite endpoint of mortality, clinical stroke, and acute kidney injury
time frame: up to 30 days
Clinical and Radiographic Brain Injury
time frame: up to 90 days
Safety of study device, as measured by Incidence of serious or protocol defined adverse events.
time frame: up to 90 days
Emboli Volume
time frame: Day 1
Change in Hopkins Verbal Learning Test
time frame: baseline and 90 days
Change in Trailmaking Tests A and B
time frame: baseline and 90 days
Change in MCG Complex Figures
time frame: baseline and 90 days
Change in Digit Span
time frame: baseline and 90 days
Change in Digit Substitution Test
time frame: baseline and 90 days
Change in COWA Verbal Fluency Test
time frame: baseline and 90 days
Change in NIH Stroke Scale
time frame: baseline and 90 days
Change in Modified Rankin Scale
time frame: baseline and 90 days
Change in Barthel Index
time frame: baseline and 90 days
Change in confusion Assessment Method (CAM) Delirium Assessment
time frame: baseline and 90 days
Survival
time frame: up to 90 days
Length of Stay hospitalization
time frame: up to 90 days
Hospital Readmissions
time frame: up to 90 days
Mortality
time frame: up to 90 days
Quality of life
time frame: up to 90 days
Device Performance
time frame: day 1

Eligibility Criteria

Male or female participants at least 60 years old.

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

Additional Information

Official title Neuroprotection In Patients Undergoing Aortic Valve Replacement
Principal investigator Annetine C Gelijns, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai.