Actively Recruiting
CTSN Embolic Protection Trial
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-07-20
842
Participants Needed
28
Research Sites
184 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective, multi-center, randomized effectiveness trial of the CardioGard Embolic Protection Cannula in high-risk valve surgery patients.
CONDITIONS
Official Title
CTSN Embolic Protection Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
Age ≥ 60 years
-
Planned de novo or redo:
- Surgical aortic valve replacement SAVR ± ascending aortic repair (if circulatory arrest is not required) ± CABG
- Mitral valve replacement (MVR) ± CABG
- Mitral Valve Repair + CABG,
- Double/Triple valve surgery ± CABG; Ross procedure These procedures can be done via a full or minimal-access sternotomy (using central aortic perfusion cannulae) with legally marketed valve(s), and can be done in combination with an left atrial appendage (LAA) closure/excision or partial/complete Maze procedure.
- Valve sparing aortic root replacement (David procedure)
- Valve sparing aortic root replacement (David procedure)
-
No evidence of neurological impairment as defined by a NIHSS ≤1 and modified Rankin scale (mRS) ≤2 within 30 days prior to randomization
-
Ability to provide informed consent and comply with the protocol
You will not qualify if you...
- History of clinical stroke within 3 months prior to randomization
- Cerebral and or aortic arch arteriography or interventions within 3 days of the planned procedure
- Coronary catheterization within 3 days of index procedure, and the required repeat NIHSS score post-catheterization is worse than the screening/baseline NIHSS score conducted prior to the catheterization
- Active endocarditis at time of randomization with vegetation criteria
- Clinical signs of cardiogenic shock or treatment with IV inotropic therapy prior to randomization
- Participation in an interventional (drug or device) trial
- Isolated mitral valve repair, isolated tricuspid valve repair or combined mitral valve repair and tricuspid valve repair
- Anticipated requirement for prolonged mechanical ventilation greater than 48 hours after surgery in the opinion of the investigator
- Planned concomitant carotid endarterectomy during index surgical procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
CHI St. Vincent Heart Institute
North Little Rock, Arkansas, United States, 72117
Actively Recruiting
2
Keck Hospital of the University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
3
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Indiana University
Bloomington, Indiana, United States, 47405
Not Yet Recruiting
5
Indiana Ohio Heart
Fort Wayne, Indiana, United States, 46804
Actively Recruiting
6
Ochsner Clinic
New Orleans, Louisiana, United States, 70506
Actively Recruiting
7
Maine Medical Center
Portland, Maine, United States, 04102
Actively Recruiting
8
Johns Hopkins Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
9
University of Maryland
College Park, Maryland, United States, 20742
Actively Recruiting
10
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
11
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
12
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
13
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Actively Recruiting
14
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
15
New York Presbyterian-Cornell Medical Center
New York, New York, United States, 10065
Not Yet Recruiting
16
NYU Langone Hospital Brooklyn
New York, New York, United States, 11220
Actively Recruiting
17
Northwell Health
New York, New York, United States, 21287
Actively Recruiting
18
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
19
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
20
University Hospitals
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
21
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
22
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
23
University of Virginia
Charlottesville, Virginia, United States, 22903
Not Yet Recruiting
24
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
25
London Health Sciences Centre
London, Ontario, Canada
Not Yet Recruiting
26
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Not Yet Recruiting
27
Montreal Heart Institute
Montreal, Quebec, Canada
Not Yet Recruiting
28
Hôpital Laval
Québec, Quebec, Canada, QC G1V 4G5
Not Yet Recruiting
Research Team
C
Claudia Merlin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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