NCT02389894

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
383

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
2 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

April 29, 2019

Completed
Last Updated

April 29, 2019

Status Verified

April 1, 2019

Enrollment Period

1.8 years

First QC Date

March 10, 2015

Results QC Date

December 12, 2017

Last Update Submit

April 26, 2019

Conditions

Aortic StenosisBrain InfarctionCerebrovascular AccidentStroke

Keywords

Embolic Protection DeviceStrokeBrain InfarctionatheromaAortic Valve Replacement

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction

    freedom from CNS infarction, defined as brain, spinal cord, or retinal cell death attributable to ischemia based on neuropathological, neuroimaging, or clinical evidence of permanent injury based on symptoms persisting \> 24 hours, with overt symptoms or no known symptoms. All patients will be assessed by 1.5 T (3.0 T is acceptable if 1.5 T not available) Diffusion-weighted imaging (DWI) at 7 (± 3) days post procedure for presence of brain lesions and to measure the number and volume of any present lesions.

    up to 10 days post procedure

Secondary Outcomes (20)

  • Number of Participants With a Composite Endpoint of Mortality, Clinical Stroke, and Acute Kidney Injury

    up to 30 days

  • Number of Patients With Clinically Apparent Stroke at 7 Days

    at 7 days

  • Presence of Radiographic Infarcts

    up to 10 days

  • Total Infarct Volume

    Day 7

  • Decline in Overall Neurocognition

    baseline and 90 days

  • +15 more secondary outcomes

Study Arms (3)

Embol-X Embolic Protection Device

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.

Device: Embol-X Embolic Protection Device

CardioGard Cannula

ACTIVE COMPARATOR

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

Device: CardioGard Cannula

Standard Cannula

NO INTERVENTION

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

Interventions

Embol-X Embolic Protection DeviceDEVICE

per the manufacturer's instructions for use (IFU).

Also known as: Edwards Embol-X embolic protection device
Embol-X Embolic Protection Device
CardioGard CannulaDEVICE

CardioGard Cannula, per the manufacturer's instructions for use (IFU).

Also known as: CardioGard Emboli Protection Cannula
CardioGard Cannula

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization
  • Concurrent participation in an interventional (drug or device) trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

University of Southern California

Los Angeles, California, 90033, United States

Location

Emory University

Atlanta, Georgia, 30308, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

NIH Heart Center at Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Montefiore Einstein Heart Center

The Bronx, New York, 10467, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor Research Institute

Plano, Texas, 75093, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

University of Alberta Hospital

Edmonton, Alberta, T6G2B7, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Institut Universitaire de Cardiologie de Quebec (Hopital Laval)

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (3)

  • Messe SR, Overbey JR, Thourani VH, Moskowitz AJ, Gelijns AC, Groh MA, Mack MJ, Ailawadi G, Furie KL, Southerland AM, James ML, Moy CS, Gupta L, Voisine P, Perrault LP, Bowdish ME, Gillinov AM, O'Gara PT, Ouzounian M, Whitson BA, Mullen JC, Miller MA, Gammie JS, Pan S, Erus G, Browndyke JN; Cardiothoracic Surgical Trials Network (CTSN) Investigators. The impact of perioperative stroke and delirium on outcomes after surgical aortic valve replacement. J Thorac Cardiovasc Surg. 2024 Feb;167(2):624-633.e4. doi: 10.1016/j.jtcvs.2022.01.053. Epub 2022 Mar 18.

    PMID: 35483981DERIVED

  • 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.

    PMID: 30007783DERIVED

  • 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.

    PMID: 28787505DERIVED

MeSH Terms

Conditions

Aortic Valve StenosisBrain InfarctionStrokePlaque, Atherosclerotic

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPathological Conditions, Anatomical

Results Point of Contact

Title
Annetine C. Gelijns, PhD
Organization
Icahn School of Medicine at Mount Sinai
annetine.gelijns@mssm.edu
212-659-9568

Study Officials

  • Annetine C Gelijns, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

  • Richard Weisel, MD

    Toronto General Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Department of Population Health Science & Policy, Edmond A. Guggenheim Professor of Health Policy Co-Director, InCHOIR

Study Record Dates

First Submitted

March 10, 2015

First Posted

March 17, 2015

Study Start

March 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

April 29, 2019

Results First Posted

April 29, 2019

Record last verified: 2019-04

Locations

CA(4)US(14)