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Cannula
Neuroprotection in Patients Undergoing Aortic Valve Replacement
N/A
Waitlist Available
Led By Annetine C Gelijns, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
No Placebo-Only Group
Summary
To evaluate the efficacy and safety of embolic protection devices to reduce ischemic brain injury in patients undergoing surgical aortic valve replacement (AVR).
Eligible Conditions
- Stroke
- Aortic Stenosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction
Secondary study objectives
Barthel Index <= 80
Decline in Neurocognitive Function in the Auditory-Verbal Simple Attention Domain at 90 Days
Decline in Neurocognitive Function in the Executive Function Domain at 90 Day
+15 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Active Control
Group I: CardioGard CannulaActive Control1 Intervention
The Cardiogard embolic protection device is a curved tip 24-French aortic perfusion cannula.
Group II: Embol-X Embolic Protection DeviceActive Control1 Intervention
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.
Group III: Standard CannulaActive Control1 Intervention
Patients in this arm will receive the standard of care surgical procedure using a cannula of the surgeon's choosing.
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,944 Previous Clinical Trials
47,799,449 Total Patients Enrolled
89 Trials studying Stroke
537,609 Patients Enrolled for Stroke
Icahn School of Medicine at Mount SinaiLead Sponsor
914 Previous Clinical Trials
570,496 Total Patients Enrolled
15 Trials studying Stroke
6,935 Patients Enrolled for Stroke
Annetine C Gelijns, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
4 Previous Clinical Trials
3,840 Total Patients Enrolled
1 Trials studying Stroke
3,200 Patients Enrolled for Stroke
Richard Weisel, MDStudy ChairToronto General Hospital
3 Previous Clinical Trials
928 Total Patients Enrolled