Neuroprotection in Patients Undergoing Aortic Valve Replacement

Mount Sinai Health System

Status: Completed

Conditions: Cerebrovascular Accident; Stroke; Brain Infarction; Aortic Stenosis

Treatments: Device: Embol-X Embolic Protection Device; Device: CardioGard Cannula

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02389894

GCO 08-1078-0009

2U01HL088942-07 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 383 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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383 participants in 3 patient groups

Embol-X Embolic Protection Device

Active Comparator group

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.

Treatment:

Device: Embol-X Embolic Protection Device

CardioGard Cannula

Active Comparator group

Description:

The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.

Treatment:

Device: CardioGard Cannula

Standard Cannula

No Intervention group

Description:

Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.