Actively Recruiting
Embolic Protection in Patients Undergoing High-Risk Valve Surgery
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-05-29
842
Participants Needed
28
Research Sites
N/A
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
Researchers are evaluating the CardioGard Embolic Protection Cannula in patients aged 60 and older undergoing different types of high-risk valve surgery, with or without coronary artery bypass grafting (CABG). This prospective, multicenter, randomized controlled trial compares the safety and effectiveness of the CardioGard device to a standard aortic cannula during surgery. The study also includes an ancillary sub-study investigating the relationship between sleep disturbances and post-operative delirium in this patient population. Participants are randomly assigned in the operating room to either receive the CardioGard Embolic Protection Cannula, which combines standard blood flow with a suction mechanism to capture debris during surgery, or to a standard aortic cannula chosen by the surgeon. Randomization is stratified by surgical procedure and location. The enrollment period is expected to last 30 months, with follow-up extending for 12 months after the procedure. The ancillary sub-study includes about 300 participants and focuses on sleep patterns before and after surgery. During the study, patients undergo evaluations including neurological assessments, cognitive tests, and monitoring for events like ischemic stroke, acute kidney injury, delirium, and mortality within days and months after surgery. Researchers also track sleep quality and circadian rhythm disruptions using questionnaires and actigraphy. Safety and clinical outcomes are monitored throughout hospitalization and during follow-up visits up to one year. The primary outcomes include stroke, acute kidney injury, death, and delirium occurring shortly after surgery.
CONDITIONS
Brief Title
CTSN Embolic Protection Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Planned to undergo surgical aortic valve replacement, mitral valve replacement or repair, double/triple valve surgery, or valve sparing aortic root replacement
- Surgery may include coronary artery bypass grafting (CABG) and be performed via full or minimal-access sternotomy
- Use of legally marketed valve(s) is required
- May include left atrial appendage closure/excision or partial/complete Maze procedure
- No evidence of neurological impairment with NIH Stroke Scale score ≤1 and modified Rankin Scale score ≤2 within 30 days prior to randomization
- Ability to provide informed consent and comply with the study protocol
You will not qualify if you...
- History of clinical stroke within 3 months prior to randomization
- Cerebral or aortic arch imaging or intervention within 3 days before surgery
- Coronary catheterization within 3 days before surgery with worsening neurological scores
- Active endocarditis with vegetations at randomization
- Clinical signs of cardiogenic shock or receiving intravenous inotropic therapy before randomization
- Participation in another interventional drug or device trial
- Isolated mitral or tricuspid valve repair or combined mitral and tricuspid valve repair
- Expected need for mechanical ventilation longer than 48 hours after surgery
- Planned carotid endarterectomy during the surgical procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day and immediate recovery period
Participants undergo high-risk valve surgery using either the CardioGard Embolic Protection Cannula or a standard aortic cannula. The surgery may include valve replacement or repair, and possibly coronary artery bypass grafting, performed via full or minimal-access sternotomy. Immediate post-operative care begins after surgery.
1 surgery visit and hospital stay
Duration - Up to 12 months post-surgery
Participants are monitored for neurological outcomes, kidney function, delirium, and other recovery parameters for up to 7 days post-surgery. Additional cognitive and functional assessments occur up to 12 months after surgery to evaluate recovery and long-term effects.
Multiple visits including assessments at 7 days, 30 days, 90 days, and 12 months
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
Withdrawn
5
Indiana Ohio Heart
Fort Wayne, Indiana, United States, 46804
Withdrawn
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
Withdrawn
16
NYU Langone Hospital Brooklyn
New York, New York, United States, 11220
Withdrawn
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
Withdrawn
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
Actively Recruiting
26
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Actively 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
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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